The Siege™ Vascular Plug (“Device”) is a self-expanding braided nitinol vascular occlusion implant that is supplied with components used for implantation. The Device has radiopaque marker bands attached to each end and a screw attachment for connection to a Delivery Wire. The Device is packaged collapsed within a Loader and attached to a 180cm Delivery Wire that is provided within a hoop dispenser. Touhy Borst Valves are provided for flushing and maintaining hemostasis. A Torque Device is provided for releasing the Device.

The Siege™ Vascular Plug has been designed with a material, size, configuration and shape that allows introduction through recommended 0.027" inner diameter commercial microcatheters for the occlusion of blood vessels in the peripheral vasculature. The Siege™ Vascular Plug Devices are provided in four different diameters (3mm, 4mm, 5mm, 6mm) to treat different sized blood vessels in the peripheral vasculature. The Siege™ Vascular Plug is designed to be used under fluoroscopy for delivery and implantation in the peripheral vasculature. The main users of the device are physicians trained in vascular embolization.

AI/ML Overview

This document is a 510(k) summary for the Merit Siege Vascular Plug. It states that clinical testing was not required for the determination of substantial equivalence. Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training set information is not applicable to this submission.

The summary focuses on comparing the subject device to predicate devices (KA Medical Micro Plug Set K182944, Amplatzer® Vascular Plug K031810, Micro Vascular Plug System K123803, and Micro Vascular Plug System K133282) based on technological characteristics and performance testing.

Here's what can be extracted from the provided text regarding acceptance criteria and performance, although it doesn't fit the requested table format precisely due to the lack of quantitative criteria:

Acceptance Criteria and Reported Device Performance (Qualitative)

Since no specific quantitative acceptance criteria are provided in the document beyond meeting "predetermined acceptance criteria" and being "comparable to predicate devices," this table is formed qualitatively based on the tests performed and the general statement of meeting criteria.

Acceptance Criteria Category	Reported Device Performance
Performance Testing
Simulated Use (Loader Flushing, Device Handoff, Device Advancement, Deployment, Apposition, Recapture, Redeployment, Device Release)	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Set Strength	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Delivery Wire Proximal Weld Strength	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Loader Fluid Leakage Under Pressure	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Loader Hub to Loader Tube Peak Tensile Force	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Luer Testing	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Fatigue Testing	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Nickel Leach	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Radial Force	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Migration Resistance	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Nitinol Austenite Finish Temperature	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
MRI Testing	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Corrosion Testing	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Size Designation	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Packaging Tests
Visual	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Dye Penetration Testing	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Bubble Leak Test	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Seal Peel Strength	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Burst Test	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Sterilization	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Shelf Life	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Biocompatibility	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
GLP Animal Study	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices (covering Acute performance, Chronic performance, Tissue response).

The document explicitly states that clinical testing was not required for the determination of substantial equivalence (page 10). Therefore, the following requested information is not applicable in this context:

Sample size used for the test set and the data provenance: Not applicable as no clinical test set was used. "A battery of testing was conducted, on the subject Merit Siege™ Vascular Plug, in accordance with protocols based on requirements outlined in guidance's and Performance industry standards." These tests were likely in vitro or in vivo (animal study).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there was no clinical test set requiring expert ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as there was no clinical test set requiring adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a vascular plug, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a vascular plug, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical tests, the "ground truth" would be the engineering specifications, industry standards, and biological responses observed in biocompatibility and animal studies, rather than a clinical ground truth. For the animal study, outcomes such as acute performance, chronic performance, and tissue response were evaluated.
The sample size for the training set: Not applicable as no machine learning algorithm was involved.
How the ground truth for the training set was established: Not applicable as no training set for a machine learning algorithm was involved.

In summary, this 510(k) submission for the Merit Siege Vascular Plug demonstrates substantial equivalence through non-clinical testing (performance, biocompatibility, sterilization, and animal studies) rather than clinical studies requiring human data, expert review, or AI performance metrics.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.

Merit Medical System, Inc. Siobhan King Senior Regulatory Affairs Specialist Parkmore Business Park West Galway, Ireland

Re: K212817

Trade/Device Name: Merit Siege Vascular Plug Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: November 5, 2021 Received: November 12, 2021

Dear Siobhan King:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Misti Malone, PhD Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212817

Device Name Merit Siege Vascular Plug

Indications for Use (Describe)

The Siege Vascular Plug is indicated for arterial embolization in the peripheral vasculature.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

GeneralProvisions	Submitter Name:	Merit Medical Systems, Inc.
	Address:	1600 West Merit ParkwaySouth Jordan, UT 84095
	Telephone Number:	(+353) 91 703700 (Ext. 3061)
	Fax Number:	(+353) 91 680104
	Contact Person:	Mark Mullaney
	Registration Number:	1721504
	Correspondent Name:	Merit Medical Ireland Ltd.
	Address:	Parkmore Business ParkParkmore, Galway, Ireland
	Telephone Number:	(+353) 91 703700 (Ext. 3052)
	Fax Number:	(+353) 91 680104
	Contact Person:	Siobhan King
	Date of Preparation:	31 August 2021
	Registration Number:	9616662
SubjectDevice	Trade Name:	Merit Siege Vascular Plug
	Common/Usual Name:	Vascular Device for promotingembolization
	Classification Name:	Vascular Embolization Device
PredicateDevice	Premarket Notification Predicate:
	Trade Name:	Dr. Amplatz Micro Plug
	Classification Name:	21 CFR 870.3300 VascularEmbolization Device
	Premarket Notification:	K182944
	Manufacturer:	KA Medical
	Premarket Notification Reference Device#1:
	Trade Name:	Amplatzer® Vascular Plug (AVP)
	Classification Name:	21 CFR 870.3300 VascularEmbolization Device
	Premarket Notification:	K031810
	Manufacturer:	Abbott
Premarket Notification Reference Device#2:
	Trade Name:	Micro Vascular Plug System(MVP)
	Classification Name:	21 CFR 870.3300 VascularEmbolization Device
	Premarket Notification:	K123803
	Manufacturer:	Medtronic
	Premarket Notification Reference Device#3:
	Trade Name:	Micro Vascular Plug System
		(MVP)
	Classification Name:	21 CFR 870.3300 VascularEmbolization Device
	Premarket Notification:	K133282
	Manufacturer:	Medtronic

Classification	Class II
	21 CFR § 870.3300
	Product code: KRD
	Division of Cardiovascular Devices

Intended Use	The Siege Vascular Plug is indicated for arterial embolizationin the peripheral vasculature.

DeviceDescription	The Siege™ Vascular Plug (“Device”) is a self-expandingbraided nitinol vascular occlusion implant that is supplied withcomponents used for implantation. The Device has radiopaquemarker bands attached to each end and a screw attachment forconnection to a Delivery Wire. The Device is packagedcollapsed within a Loader and attached to a 180cm DeliveryWire that is provided within a hoop dispenser. Touhy BorstValves are provided for flushing and maintaining hemostasis. ATorque Device is provided for releasing the Device.
	The Siege™ Vascular Plug has been designed with a material,size, configuration and shape that allows introduction throughrecommended 0.027" inner diameter commercialmicrocatheters for the occlusion of blood vessels in theperipheral vasculature. The Siege™ Vascular Plug Devices areprovided in four different diameters (3mm, 4mm, 5mm, 6mm) totreat different sized blood vessels in the peripheral vasculature.The Siege™ Vascular Plug is designed to be used underfluoroscopy for delivery and implantation in the peripheralvasculature. The main users of the device are physicians trainedin vascular embolization.
Comparisonto Predicate	DeviceCharacteristic	Subject MeritSiege™ Vascular Plug	Predicate KA Medical,Micro Plug Set(K182944)
	510(k) #	K212817	K182944
	Product Code	KRD	Same
	IndicationsforUse/IntendedUse	indicated for arterialembolization in theperipheral vasculature	Same
	ComponentsSupplied inthe SterilePackage	Siege Vascular Plug Loader Delivery Wire Torque Device Tuohy Borst Valves	Micro Plug Device Loader Delivery Wire Torque Device Tuohy Borst Valves Delivery Catheter
	ComponentConstructionMaterials	Plug Nitinol braid Platinum-iridium radiopaque marker bands 316 L Stainless Steel female threaded component at proximal end	Plug Same
		Delivery Wire Nitinol ground core wire, stainless steel screw, stainless steel outer coil. Tuohy Borst Valve Body and Cap – polycarbonate Seal – silicone, blue Washer - PTFE Loader Rilsan (nylon) tubing with Vestamid hub and PTFE liner	Delivery Wire Same Tuohy Borst Valve Same Loader Rilsan (nylon) tubing with Pebax hub, LDPE strain relief and PTFE liner
		Torque Device Polycarbonate cap, polypropylene body, brass collet Delivery Catheter No longer supplied – compatible with commercially available 0.027" inner diameter microcatheters	Torque Device Polybutylene Terephthalate (PBT) Delivery Catheter Nylon, Pebax, Stainless steel braid, PTFE, Grilamed, platinum-iridium, Hydrophilic coating
Dimensions	Siege Vascular Plug	Micro Plug Set
	Diameter sizes: 3,4,5 & 6 mmConstruction:• 3 lobes• 2 braid layers - each layer is comprised of 72 wires with diameters of 0.0008 and/or 0.001 inches• Female threaded bushing 0.052" length• Markerband ID 0.016"	Diameter sizes: 3,4,5 & 6 mmConstruction:• 3 lobes• 2 braid layers - each layer is comprised of 72 wires with diameter of 0.001 inches• Female threaded bushing 0.047" length• Markerband ID 0.018"
	DeviceDiameter	DeviceDiameter
	DeviceLength*	DeviceLength*
	3 mm6.0 mm	3 mm5.2 mm
	4 mm5.2 mm	4 mm5.2 mm
	5 mm5.2 mm	5 mm5.2 mm
	6 mm5.2 mm	6 mm5.2 mm
	*unconstrained - elongates when constrained with oversizing	*unconstrained - elongates when constrained with oversizing
	Delivery Wire• Reduction in OD to 0.022" outer HHS	Delivery Wire• OD 0.024" outer HHS
	Loader• 0.026" ID with tapered distal tip geometry, length increased to 11.2"	Loader• 0.029" ID with chamfered distal tip geometry, length 8.75"
	Touhy Valve• FLO40	Touhy Valve• Same
	Torque Device• 3 Part torque device	Torque Device• 2 part torque device
	Delivery Catheter (not included)Introduction through 0.027" inner diameter commercially compatible microcatheters up to 150 cm long is recommended.	Delivery Catheter included:2.9F, 125 cm long, .028-inch inner diameter with hydrophilic coating
Single Use	Yes	Same
Anatomicalsite	Peripheral vasculature	Same
Sterilization	Sterile/Ethylene Oxide SAL 10-6	Same
Shelf Life	1 year	3 years
Pyrogenicity	Yes	Same
Packaging	Length of backing card, pouch and box designed to accommodate all components (except a microcatheter). Similar packaging but will be shorter in length to accommodate the removal	Length of backing card, pouch and box designed to accommodate all components and included catheter.

	of the catheter and willinclude a retention clip to
	anchor the delivery wire.
Principles ofoperation	The Delivery Wire withattached Siege VascularPlug is transferred into arecommended 0.027" innerdiameter commerciallycompatible microcatheterusing the provided Loader.The Plug is advancedthrough a recommendedmicrocatheter to thetargeted position. TheSiege Vascular Plug isadvanced out of themicrocatheter; the Siege	The Delivery Wire withattached Micro Plug SetDevice is transferred intothe Delivery Catheterusing the providedLoader. The plug isadvanced through thesupplied DeliveryCatheter to the targetedposition. The Micro PlugSet Device is advancedout of the DeliveryCatheter; the Micro PlugSet Device self-expands
	Vascular Plug device self-expands recovering its pre-set shape and cross-sectionally occludes thevasculature. If Deviceposition is unsatisfactory,the device can berepositioned or removed. Ifposition is satisfactory, theDelivery Wire is rotatedcounterclockwise using theprovided Torque Device torelease the Siege VascularPlug	recovering the pre-setshape and cross-sectionally occludes thevasculature. If Deviceposition is unsatisfactory,the Device can berepositioned, redeployedor removed. If position issatisfactory, the DeliveryWire is rotatedcounterclockwise usingthe provided TorqueDevice to release theMicro Plug Set Device

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The subject equivalent MEN
TIN Slege"" Vascu its intended ar Plug is substantially
use/indications 11 use,

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technology/principle of operation, materials and performance specification to the predicate KA Medical Micro Plug Set (K182944).

A comparison of the technological characteristics is summarized in the table below:

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No performance standards have been established under section 514 of the Food, Drug and Cosmetic Act for these devices. However, Vascular and Neurovascular Embolization Devices are subject to the Special Controls specified in "Vascular and Neurovascular Embolization Devices - Class II Special Controls Guidance Document for Industry and FDA Staff", issued on December 29, 2004. A battery of testing was conducted, on the subject Merit Siege™ Vascular Plug, in accordance with protocols based on requirements outlined in guidance's and Performance industry standards and these were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence. The evaluations included performance testing, biocompatibility, sterilization, and animal studies.

Where appropriate, the tests were based on the requirements of the following documents:

FDA Guidance documents:

Safety &

Tests

· Vascular and Neurovascular Embolization Devices Class II Special Controls Guidance Document for Industry and FDA Staff (December 29, 2004)

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· Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol. Guidance for Industry and FDA Staff (July 09, 2021)
Q3D(R1) Elemental Impurities Guidance for Industry (March 2020)
· Applying Human Factors and Usability Engineering to Medical Devices to Optimize Safety and Effectiveness in Design (February 2016)
· MRI Compatibility Testing and Labelling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (May 2021)
· Select updates for Non-Clinical Engineering Tests and Recommended Labelling for Intravascular Stents and Associated Delivery Systems (August 2015)

Recognized Standards

· ISO 10555-1:2013 Intravascular Catheters-Sterile and Single-use Catheters
· ISO 80369-7:2016 Small bore connectors for liquids and qases in healthcare applications - Part 7: connectors for intravascular or hypodermic applications
· ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications- Part 20: Common test methods
· ASTM F2005 Standard Terminology for Nickel-Titanium Shape Memory Alloy
· ASTM F2004 Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
· ISO 14630:2012 Non-active surgical implants General requirements
· ASTM F2129-19a Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small implants
ASTM F3044-20 Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants
· ASTM G71-81 2014 Standard quide for conducting and evaluating galvanic corrosion tests in electrolytes
· ASTM F2052-15 Standard Test Method for the Measurement of Magnetically Induced Displacement Force on medical Devices in the Magnetic Resonance Environment
· ASTM F2182-19e Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
· ASTM F2213-17 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the

Maqnetic Resonance Environment

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· ASTM · F2119-07(2013) Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
· ASTM D4169-16 Standard Practice For Performance Testing Of Shipping Containers And Systems
· ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
· ASTM F88 / F88M 15 Standard Test Method for Seal Strength of Flexible Barrier Materials
· ASTM F2096 11(2019) Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
· ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
· ASTM · D4332-14 Standard Practice for Conditioning Containers. Packages, or Packaging Components for Testing
AAMI TIR28:2016 Product adoption and process equivalence for ethylene oxide sterilization
· ISO 2233:2001 Packaging Complete, filled transport packages and unit loads - Conditioning for testing
· ISO 11607-1:2019 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
· ISO 11607-2:2019 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
· ISO 11135:2014 Sterilization of health care products-Ethylene oxide-: Requirements for the development, validation and routine control of a sterilization process for medical devices
· ISO 10993-1:2018, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process, and the FDA Guidance for Industry, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"

The subject Merit Siege™ Vascular Plug was compared to the predicate device for various performance attributes that support substantial equivalence of the device.

The following testing was successfully completed: Performance Testing

Simulated Use Loader Flushing. Device Handoff. ● Device Advancement, Deployment, Apposition, Recapture, Redeployment, Device Release
Set Strength ●

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Delivery Wire Proximal Weld Strength ●
Loader Fluid Leakage Under Pressure ●
Loader Hub to Loader Tube Peak Tensile Force ●
Luer Testing ●
Fatique testing
Nickel leach ●
Radial Force
Migration resistance ●
Nitinol Austenite Finish Temperature
MRI Testing
Corrosion Testing ●
Size Designation ●
Packaging
- Visual o
- O Dye penetration testing
- Bubble Leak Test O
- Seal peel strength o
- o Burst Test
Sterilization
Shelf life
Biocompatibility ●
GLP Animal Study ●
- o Acute performance
- Chronic performance o
- Tissue response o

Clinical testing was not required for the determination of substantial equivalence.

All test results were comparable to the predicate devices and the subject Merit Siege™ Vascular Plug met the predetermined acceptance criteria. This has demonstrated that the subject device is substantially equivalent to the predicate device, K182944.

Based on the Indications for Use, design, safety and Summary of performance testing, the subject Merit Siege™ Vascular Plug Substantial meets the requirements that are considered essential for its Equivalence intended use and is substantially equivalent to the predicate device, KA Medical, Micro Plug Set (K182944).

Regulation Number and Section

§ 870.3300 Vascular embolization device.

(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).