The Concentric Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.

Device Description

Like the predicate device, the Modified FlowGate™ Balloon Guide Catheter is a coaxiallumen, braid-reinforced, variable stiffness catheter designed for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. A radiopaque marker is included on the distal end for angiographic visualization. A compliant balloon is mounted on the distal end to provide temporary vascular occlusion during angiographic procedures. A bifurcated luer hub on the proximal end allows attachments for flushing, inflation and aspiration. Modified FlowGate™ Balloon Guide Catheter dimensions and maximum recommended balloon inflation volume are indicated on product label.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (Modified Balloon Guide Catheter) and does not describe a study involving an AI/ML device. Therefore, it does not contain information on acceptance criteria, reported device performance in the context of AI/ML, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or the type of ground truth used for AI/ML validation.

Instead, the document focuses on demonstrating substantial equivalence of a modified medical device to its predicate devices, as required for 510(k) clearance by the FDA. The "acceptance criteria" and "study" mentioned in this document refer to the verification and validation testing performed to ensure the modified device meets its design specifications and performs as safely and effectively as the predicate devices.

Here's an interpretation of the requested information based on the provided text, adapted for a medical device rather than an AI/ML system:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a single table of acceptance criteria and reported full device performance in a summary format. Instead, it lists various tests performed and states that the results were successful or met acceptance criteria. For biocompatibility, specific results and conclusions are provided.

Here's a synthesized table based on the information available:

Acceptance Criteria Category/Test	Reported Device Performance Summary (Modified Balloon Guide Catheter)
Mechanical & Performance Tests
Dimensional Verification	Device met predetermined dimensional requirements.
Simulated Use Testing	Device and accessories were successfully used per procedural instructions in a neurovascular model.
Balloon Testing (Symmetry, Compliance, Inflation/Deflation, Fatigue, Burst, Leakage)	Tests performed successfully; balloon demonstrated appropriate symmetry, compliance, inflation/deflation rates, fatigue strength, constrained burst, and leakage.
Tensile Testing (Mechanical Integrity)	Device demonstrated mechanical integrity under tensile loads.
Distal Shaft Flexibility Testing	Force to flex the distal shaft was within acceptable limits.
Soft Tip Deflection Testing	Force to deflect the distal edge of the soft tip was within acceptable limits.
Tip Patency Testing	Device distal tip maintained patency under aspiration.
Kink Resistance	Device shaft demonstrated resistance to kinking.
Hub Luer Fitting Testing	Extension Tubing accessory demonstrated compatibility with the hub luer fitting.
Extension Tubing Aspiration	Ability to aspirate using the Extension Tubing Accessory was confirmed.
Packaging Verification	Packaging successfully protected the device following climatic conditioning and distribution simulation.
Shelf Life Testing (Product and Packaging)	Demonstrated acceptable shelf life for both product and packaging.
Biocompatibility Tests (Predicate Device K122581)
Sensitization (ISO 10993-10)	Non-sensitizer (no evidence of delayed dermal contact sensitization).
Cytotoxicity (ISO 10993-5)	Non-cytotoxic (no biological activity with L929 cells).
Intracutaneous Reactivity (ISO 10993-10)	Non-irritant (no significantly greater biological reaction than controls).
Systemic Toxicity (Acute) (ISO 10993-11)	No acute systemic toxicity (no significantly greater biological reaction than controls).
Systemic Toxicity (Rabbit Pyrogen Test) (ISO 10993-11, USP 34 <151>)	Non-pyrogenic (no individual temperature rise of 0.5°C or more).
Hemocompatibility (Hemolysis) (ASTM F756)	Non-hemolytic (0.17% direct, 0.12% indirect hemolysis above negative control).
Hemocompatibility (Complement Activation) (ISO 10993-4)	Minimal complement activation potential (no statistically significant increase in C3a; significant increase in SC5b-9).
Hemocompatibility (Thrombogenicity) (ISO 10993-4)	No significant thrombosis (Grade 0-1 observed).
Biocompatibility Screening Tests (Subject Device K131492)
Cytotoxicity (ISO 10993-5)	Non-cytotoxic (no cytotoxicity or cell lysis).
Hemocompatibility (Hemolysis) (ISO 10993-4, ASTM Direct/Extract)	Non-hemolytic (hemolytic index 0.0% direct, 0.4% extract).
Fourier Transform Infrared (FTIR) Scan (ISO 10993-18)	Materials for test article and control sample are equivalent (97.90% match for distal tip).
Physicochemical Tests (USP <661>)	Met USP <661> requirements (Non-volatile residue: 1 mg; Residue on ignition: < 1 mg; Heavy metal: < 1 ppm; Buffering capacity: < 1.0 ml).

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify general "sample sizes" for the test sets (e.g., number of catheters tested for mechanical properties) beyond implying that tests were conducted on "the subject device and accessories."
For biocompatibility tests, it does mention "Swiss Albino mice" for systemic toxicity and "rabbit blood" for hemolysis, and "dogs" for the thrombogenicity study.
Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing by Concentric Medical, Inc. or its contractors. No information on country of origin or whether it's retrospective or prospective is provided. It represents prospective testing conducted specifically for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This concept is not applicable in this context. For medical devices undergoing 510(k) clearance based on substantial equivalence, "ground truth" is established through engineering and biocompatibility testing against defined specifications and recognized standards (e.g., ISO, ASTM, USP), not expert consensus on medical images or clinical outcomes. The "experts" would be the engineers, toxicologists, and other scientists performing and evaluating the tests.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical or imaging studies involving human interpretation or subjective assessments. Here, the "adjudication" is based on objective measurements and compliance with predetermined pass/fail criteria from recognized standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. An MRMC comparative effectiveness study is performed for AI/ML systems often involving diagnostic imaging to assess the impact of an AI tool on human reader performance. This document is for a physical medical device (catheter) and such a study is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No. This is relevant to AI/ML devices, not a physical medical catheter. The device's performance is inherently standalone in that it is evaluated on its physical and material properties, not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

For the engineering and mechanical tests, the "ground truth" is defined by the engineering specifications and performance requirements derived from the intended use, risk assessment, and comparison to predicate devices, and adherence to relevant industry standards (e.g., for tensile strength, flexibility, balloon characteristics).
For biocompatibility, the "ground truth" is established by internationally recognized standards (e.g., ISO 10993 series, ASTM F756, USP <661>, USP 34 <151>) which define acceptable biological responses and material properties. Test results are compared directly against the pass/fail criteria outlined in these standards.

8. The Sample Size for the Training Set:

Not applicable. This document describes a physical medical device, not an AI/ML system, so there is no "training set." The development of the device would involve engineering design, prototyping, and iterative testing, but not in the sense of a data-driven "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

Summary

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510(k) Summary

Trade Name:	Modified Balloon Guide Catheter
Common Name:	Percutaneous Catheter
Classification Name:	Percutaneous Catheter, 21CFR 870.1250 Class II
Product Code:	DQY
Submitter:	Concentric Medical, Inc.301 E. Evelyn AvenueMountain View, CA 94041Tel 650-938-2100Fax 650-237-5230Facility Registration #2954917
Contact:	Rhoda SantosPrincipal Regulatory Affairs Specialist
Date Prepared:	September 27, 2013
Predicate Device:	Concentric Balloon Guide Catheter (K112404)Modified Concentric Balloon Guide Catheter (K122581)

Device Description

Accessories

The Modified FlowGate™ Balloon Guide Catheter is packaged with a Dilator, Rotating Hemostasis Valve, Tuohy Borst Valve with sideport, Peel Away Sheaths, Luer-Activated Valve, and Extension tubing.

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Indications for Use

The Indications for Use are the identical to that of the predicate device and are as follows:

Technological Characteristics and Product Feature Comparison:

The subject device, Modified FlowGate Balloon Guide Catheters is substantially equivalent to the predicate device in terms of:

indications for use materials fundamental scientific technology fundamental design materials and processes for packaging and sterilization of devices

A tabular comparison of the specific technological characteristics between the predicate devices and subject device is provided below.

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Product Feature Comparison of Subject Device with Predicate Devices (K112404 and
K122581)

	Feature	Predicate Device,K112404	Results
			Predicate Device,K122581	Subject Device,K131492
	Indications forUse	The Balloon GuideCatheter is indicated foruse in facilitating theinsertion and guidance ofan intravascular catheterinto a selected bloodvessel in the peripheraland neuro vascularsystems. The balloonprovides temporaryvascular occlusion duringthese and otherangiographic procedures.The Balloon GuideCatheter is also indicatedfor use as a conduit forRetrieval devices.	Same with reference tomarketed name asFlowGate™ BalloonGuide Catheter	Same as predicatedevice, K122581
	DeviceDescription	The Concentric BalloonGuide Catheter is acoaxial-lumen, braidedshaft, variable stiffnesscatheter with aradiopaque marker on thedistal end and abifurcated luer hub on theproximal end. Acompliant balloon ismounted on the distalend. BGC dimensionsand maximumrecommended ballooninflation volume areindicated on productlabel. If indicated on theproduct label, a dilator isprovided for transition tothe guidewire.	Same with reference tomarketed name asFlowGate™ BalloonGuide Catheter	Same as predicatedevice, K122581
	Outer/InnerJacket	Pebax	Same with revisions totransition lengths andmaterial durometers	Same material durometersas K122581, withrevisions to transitionlengths
	Results
Feature	Predicate Device,K112404	Predicate Device,K122581	Subject Device,K131492
Distal Tip	Pebax	Same with differentdurometer material thanpredicate device,K112404	Same with differentdurometer material thanpredicate devices
Balloon.Material	Silicone	Same with differentmaterial durometer thanpredicate device,K112404	Same with same materialdurometer as predicatedevice, K112404
Braid	Stainless Steel	Same	Same
Braid distal endsecurement	PET heat shrink	Acrylic (AcrylatedUrethane)	Cyanoacrylate, withdifferent viscosity thanCyanoacrylate used onpredicate devices
Marker Band	Platinum/Iridium	Same	Same
Catheter Hub	Polyurethane	Same	Same
Strain Relief	Polyolefin	Same	Additional Pebax strainrelief included withsubject device
Labeled ShaftInner / OuterDiameter(nominal)	Inner Diameter:0.059" (7F), 0.078" (8F)or 0.085" (9F)Outer Diameter:0.088 "(7F), 0.104 "(8F)or 0.116" (9F)	Inner Diameter:0.084inOuter Diameter:0.106in	Same as predicatedevice, K122581
Maximum outerdiameter alongeffective length	0.0945"(7F),0.1080"(8F) or0.1205" (9F)	0.1080in	Same as predicatedevice, K122581
EffectiveLengths	80cm or 95cm	90cm or 100cm	85cm and 95cm
Distal Tiplength	1.5mm	2mm	0.75mm
RadiopaqueMarker Length(nominal)	0.0400in	0.0200in	Same as predicatedevice, K122581
	Results
Feature	Predicate Device,K112404	Predicate Device,K122581	Subject Device,K131492
AccessoryDevicesProvided	Dilator	DilatorPeel Away SheathRotating HemostaticValveTuohy Borst Valvewith SideportLuer Activated Valve	Same as predicatedevice, K122581 withaddition of ExtensionTubing
PackagingMaterials andConfiguration	Polyethylene Tube andHDPE Packaging CardTwek/PE/PET Pouch	Polyethylene Tube andHDPE Packaging CardTyvek/LLDPE Pouch	Same as predicatedevice, K122581
SterilizationMethod	Eto	Same	Same
How Supplied	Sterile, Single Use	Same	Same

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Product Feature Comparison of Subject Device with Predicate Devices (K112404 and K122581)

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Product Feature Comparison of Subject Device with Predicate Devices (K112404 and K122581)

Risk Assessment

Risk assessment of the modifications has been conducted in accordance with EN ISO 14971:2012. Concentric Medical, Inc. has determined the modifications to the predicate devices raise no new questions of safety or effectiveness.

Results of verification and validation testing have demonstrated the Modified FlowGate Balloon Guide Catheters are substantially equivalent to the predicate devices. Furthermore, the modifications did not result in any new failure modes nor were there any changes to existing failure modes.

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Testing Summary

The results of verification and validation conducted on the subject device demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate devices. Specifically, the following tests were performed and successfully evaluated on the subject device and accessories:

Dimensional Verification: the ability of the device to meet predetermined dimensional requirements

Simulated Use Testing: the ability of the device and accessories to be used per procedural instructions outlined in the Instructions for Use in a neurovascular model

Balloon Testing: the symmetry and compliance of the distal balloon; balloon inflation and deflation rates; balloon fatigue strength; constrained balloon burst and leakage

Tensile Testing: the mechanical integrity of the device under tensile loads

Distal Shaft Flexibility Testing: the force to flex the distal shaft of the device

Soft Tip Deflection Testing: the force to deflect the distal edge of the soft tip

Tip Patency Testing: the ability of the device distal tip to maintain patency under aspiration

Kink Resistance: the ability of the device shaft to resist kinking

Hub Luer Fitting Testing: compatibility of the Extension Tubing accessory with the hub luer fitting

Extension Tubing Aspiration: the ability to aspirate using the Extension Tubing Accessory

Packaging Verification: the ability of the packaging to protect the finished device following climatic conditioning and distribution simulation

Shelf life testing (Product and Packaging)

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The subject device uses the same materials and processes as the predicate devices (K112404 and K122581). Biocompatibility tests were performed on the predicate devices (K112404 and K122581); results for all tests met the acceptance criteria and apply to the subject device. In addition, some biocompatibility screening tests were also performed on the subject device. The biocompatibility tests conducted on the predicate device K122581 and the subject device are summarized in the tables below:

ISO 10993Standard	Test	Results	Conclusion
ISO 10993-10	SensitizationKligman MaximizationTest - ISO	The USP 0.9% Sodium Chloridefor injection (NaCl) andCottonseed Oil (CSO) extracts ofthe test article showed noevidence of causing delayeddermal contact sensitization.	Non-sensitizer
ISO 10993-5	CytotoxicityL929 MEM Elution Test	No biological activity (Grade 0) wasobserved in the L929 mammalian cellsat 48 hours post exposure to the testarticle extract. The observed cellularresponse obtained from the positivecontrol article extract (Grade 4) andnegative control article extract (Grade0) confirmed the suitability of the testsystem.	Non-cytotoxic
ISO 10993-10	Intracutaneous ReactivityIntracutaneous InjectionTest	The sites injected with the USP 0.9%Sodium Chloride for Injection (NaCl)and Cottonseed Oil (CSO) extracts ofthe test article did not show asignificantly greater biologicalreaction than the sites injected withthe control extracts. The difference ofthe overall mean score between thetest article and the control article was0.0.	Non-irritant
ISO 10993-11	Systemic Toxicity (Acute)Systemic Injection Test	The 0.9% Sodium Chloride forInjection (NaCl) and Cottonseed Oil(CSO) extracts of the test article didnot induce a significantly greaterbiological reaction than the controlextracts, when tested in Swiss Albinomice.	No acutesystemictoxicity

Biocompatibility Tests, Results, Conclusions (Predicate device, K122581)

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ISO 10993Standard	Test	Results	Conclusion
ISO 10993-11USP 34 <151>	Systemic ToxicityRabbit Pyrogen Test,Material Mediated	No rabbit injected with the USP 0.9%Sodium Chloride for Injection (NaCl)extract of the test article showed anindividual rise in temperature of 0.5°Cor more above the baselinetemperature.	Non-pyrogenic
ASTM F756	HemocompatibilityHemolysis - Rabbit Blood- ASTM Direct andIndirect Contact	The test article exhibited 0.17%hemolysis above the level ofhemolysis exhibited by the negativecontrol via the direct method and0.12% hemolysis above the level ofhemolysis exhibited by the negativecontrol via the indirect method.	Non-hemolytic
ISO 10993-4	HemocompatibilityComplementActivation Assay	The plasma exposed to test articleexhibited no statistically significantincrease in C3a when compared tothe untreated control and the negativecontrol after 90 minute exposure.The plasma exposed to test articleexhibited a statistically significantincrease in SC5b-9 when compared tothe untreated control and the negativecontrol after 90 minute exposure.	Minimalcomplementactivationpotential
ISO 10993-4	HemocompatibilityThrombogenicity Study inDogs	No significant thrombosis with a Gradeof 0 (a very small clot is acceptable)was observed in 1 out of 2 test sitesand 1 out of 2 control sites. Minimalthrombosis with a Grade of 1(thrombus found at one location) wasobserved in 1 out of 2 test sites and 1out of 2 control sites.	No significantthrombosis

Biocompatibility Tests Results Conclusions (Predicate device, K122581), continued

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ISO 10993Standard	Test	Results	Conclusion
ISO 10993-5	CytotoxicityL929 MEM Elution Test	No cytotoxicity or cell lysis was notedin any of the test wells. No pH shiftwas observed at 48 hours. Thereagent control, negative control andthe positive control performed asanticipated.	Non-cytotoxic
ISO 10993-4	HemocompatibilityASTM Hemolysis (Directcontact and extract test)	The hemolytic index for the test articlein direct contact with blood was 0.0%and the hemolytic index for the testarticle extract was 0.4%	Non-hemolytic
ISO 10993-18	Fourier TransformInfrared (FTIR) Scan(+ control sample)	The distal 1mm white tip was scannedand compared to the control sample.The samples had a match of 97.90%.	Materials fortest article andcontrol sampleare equivalent.
ISO 10993-18	Physicochemical TestsPlastics (USP <661>)	Non-volatile residue: 1 mgResidue on ignition: < 1 mgHeavy metal: < 1 ppmBuffering capacity: < 1.0 ml	Met USP <661>requirements

・

Biocompatibility Screening Tests. Results, Conclusions (Subject device, K131492)

The biocompatibility results demonstrate that the subject device is biocompatible.

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Summary of Substantial Equivalence

The subject device, Modified FlowGate Balloon Guide Catheter, is substantially equivalent to the predicate devices with regard to device design, materials, intended use, and patient population. The conclusions drawn from the risk assessments, verification and validation testing conducted demonstrate that the subject device performs as designed, is as safe, as effective, and performs as well as or better than the predicate devices.

{10}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002

October 3, 2013

Concentric Medical, Inc. % Ms. Rhoda Santos Principal Regulatory Affairs Specialist 301 East Evelyn Avenue Mountain View, CA 94041

Re: K131492

Trade/Device Name: Modified FlowGate™ Balloon Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutancous Catheter Regulatory Class: Class II Product Code: DQY Dated: August 21, 2013 Received: August 22, 2013

Dear Ms. Santos:

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. 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 complics 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 (reporting of medical

{11}------------------------------------------------

Page 2 - Ms. Rhoda Santos

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Joyce M. Whang -S

Victor Krauthamer, Ph.D. for Acting Division Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K131492

Device Name: Modified FlowGate™ Balloon Guide Catheter

Indications For Use:

Prescription Use كي__________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Joyce M. Whang -S

Page 1 of 1

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).