The QuickClear Mechanical Thrombectomy System is intended for removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.

Device Description

The QuickClear Mechanical Thrombectomy System is an aspiration thrombectomy system designed for removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. The QuickClear Mechanical Thrombectomy System removes thrombus from the peripheral vasculature using continuous vacuum aspiration, through a single lumen aspiration catheter. The system components are sterile, single-use devices that are sterilized using Ethylene Oxide (EO). The QuickClear Mechanical Thrombectomy System comprises the following devices and accessories:

QuickClear Aspiration Pump
A 60cc Syringe
QuickClear Aspiration Catheters: Catheters are available in the following sizes: 6F straight tip, 8F straight tip, 8F shaped tip and 10F shaped tip.
An Obturator is supplied with the 8F and 10F catheters.
A Waste Collection Bag

AI/ML Overview

This document is a 510(k) summary for the QuickClear Mechanical Thrombectomy System, seeking substantial equivalence to a predicate device. It primarily details the device's design, intended use, and a comparison to existing devices. It does not describe the acceptance criteria or a study proving the device meets performance criteria for a diagnostic tool (e.g., an AI-powered one).

Instead, this device is a mechanical thrombectomy system, meaning it physically removes thrombus (blood clots). The testing described is for the physical performance and safety of a medical device, not the diagnostic performance of an AI algorithm.

Therefore, I cannot extract the requested information (acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert qualifications for ground truth, MRMC study, etc.) from this document. This document pertains to the regulatory clearance of a mechanical medical device, not a diagnostic AI system.

Summary

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November 1, 2021

Volcano AtheroMed Inc. Anna Stephen Regulatory Operations Specialist 1530 O'Brien Drive, Suite A Menlo Park, California 94025

Re: K193197

Trade/Device Name: QuickClear Mechanical Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ

Dear Anna Stephen:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 20, 2020. Specifically, FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075, Gregory.Oconnell(@FDA.HHS.gov.

Sincerely,

Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2021.11.01 15:10:59 -04'00'

Gregory O'Connell 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

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April 20, 2020

Volcano AtheroMed Inc. Ms. Anna Gloria Stephen Regulatory Operations Specialist 1530 O'Brien Drive, Suite A Menlo Park, California 94025

Re: K193197

Trade/Device Name: QuickClear Mechanical Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: March 20, 2020 Received: March 23, 2020

Dear Ms. Stephen:

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/cfpmn/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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see 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 mediation-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.

Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2020.04.20

Enclosure

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Indications for Use

510(k) Number (if known) K193197

Device Name

QuickClear Mechanical Thrombectomy System

Indications for Use (Describe)

The QuickClear Mechanical Thrombectomy System is intended for removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary 5

Submitter Information: Date of 510(k) Summary Preparation: April 20, 2020 Name and Address of Manufacturer: Volcano AtheroMed, Inc. 1530 O'Brien Drive, Suite A Menlo Park, CA 94025 Establishment Registration Number: 3008847191 Anna Gloria Stephen Contact Person: Phone: (612) 666-3260 Fax: (916) 638-8812 Email: annagloria.stephen@philips.com Subject Device Information: Device Trade Name: QuickClear Mechanical Thrombectomy System Common Name: Aspiration System Regulation Description: Embolectomy Catheter Regulation Number: 21 CFR 870.5150 Product Code: DXE Device Class: Class II Classification Panel: Cardiovascular

This 510(k) Summary was prepared in accordance with 21 CFR 807.92 (c)

Predicate Device: Primary: Penumbra INDIGO Aspiration System 510(k) Number: K180939, DXE, 870.5150

Reference: Teleflex Pronto .035" Extraction Catheter 510(k) Number: K070403, DXE, 870.5150 serves as a reference predicate with similar indications for use and the same catheter size (10F).

Reference: Phoenix 2.4 mm Atherectomy Plus System

510(k) Number: K181877, MCW, 870.4875 serves as a reference predicate for the QuickClear Aspiration Pump that was cleared as the Phoenix Aspiration Pump in K181877.

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Intended Use/ Indication for Use:

The QuickClear Mechanical Thrombectomy System is intended for removal of fresh, soft emboli and thrombi from vessels of the peripheral anterial and venous systems.

Device Description:

. QuickClear Aspiration Pump: The QuickClear Aspiration Pump is identical to the previously cleared Phoenix Aspiration Pump that is part of the Phoenix 2.4 Atherectomy Plus System (K181877) and remains unchanged as part of the QuickClear Mechanical Thrombectomy System. The pump is sterile, single-use, battery-operated, has an ON/OFF button, and serves as a vacuum source for aspirating thrombus from target vessel/s out of the QuickClear Aspiration Catheter via the pump aspiration tubing into a waste collection bag (connected to the pump outlet). Aspiration is controlled via an inline flow control switch. The aspiration pump is non-patient contacting.
- . A 60cc Syringe assists in priming the pump tubing and purging the aspiration system of air. The syringe can also be used to provide additional vacuum by pulling the plunger during active aspiration. The 60cc Syringe is provided with the Aspiration Pump Kit
QuickClear Aspiration Catheters: Catheters are available in the following sizes: 6F straight tip, 8F straight tip, 8F shaped tip and 10F shaped tip. The QuickClear Aspiration Catheters continuously aspirate and remove thrombus and emboli from the vasculature when connected to the QuickClear Aspiration Pump. The catheters have a marker band tip for enhanced fluoroscopic visualization and are hydrophilic-coated to enhance lubricity. A Hemostasis Valve Y-connector is supplied with the catheter and connects to the proximal catheter hub. The QuickClear Aspiration Pump tubing is attached to the Hemostasis Valve Y-connector port to provide vacuum to the catheter for removal of thrombus.
- . An Obturator is supplied with the 8F and 10F catheters. The Obturator is intended to be used as an over-the-wire (OTW) accessory, positioned within the lumen of the catheter, for tracking over commercially available 0.035" guidewires. The Obturator provides catheter support and atraumatic advancement through the vasculature during catheter placement.
A Waste Collection Bag is connected to the proximal end of the aspiration pump tubing ● to collect aspirated material.

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Comparison with Predicate:

The QuickClear Mechanical Thrombectomy System has been assessed for substantial equivalence relative to the currently marketed Penumbra INDIGO Aspiration System (K180939) as the predicate device, along with consideration of two additional reference devices, the Phoenix 2.4mm Atherectomy Plus System (K181877) and the Teleflex Pronto .035" Extraction Catheter (K070403). The indications for QuickClear Mechanical Thrombectomy System are similar to the indications for use of the predicate device Penumbra INDIGO Aspiration System. The QuickClear System and the INDIGO System have similar technological characteristics and operating principles. Both devices consist of two main components Aspiration Catheter and Aspiration Pump. The pump provides continuous vacuum through the single-lumen catheter for the removal of fresh, soft emboli and thrombi from the peripheral vasculature.

The basic operating principle of the Pronto Extraction Catheteris similar to the QuickClear 10F Aspiration Catheter. The Pronto .035" Extraction Catheter serves as a reference predicate with similar indications for use and technological characteristics based on the 10F catheter size to compare with the 10F subject catheter size targeting safe thrombus removal from the larger diameter venous and arterial vessels. Both catheters are designed to be delivered through a 10F or larger introducer sheath over a 0.035" guidewire.

Additionally, the Phoenix 2.4 mm Atherectomy Plus System serves as a direct reference predicate since the QuickClear Aspiration Pump is identical to the Phoenix Aspiration Pump cleared in K181877.

Any differences between the subject and predicate device were evaluated through technological comparison (also taking into account the noted reference devices), design verification and validation testing to demonstrate that the subject QuickClear Mechanical Thrombectomy System is substantially equivalent to the currently marketed predicate device..

Some of the similarities and differences between the subject device and the predicate devices are outlined in Table 5-1 below

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Table 5-1:Comparative Summary of QuickClear Mechanical Thrombectomy System and Predicate Devices
Attribute	Subject Device	Predicate Device	Reference Device	Direct Reference Device
Trade Name	QuickClear Mechanical	Penumbra INDIGO Aspiration	Teleflex Pronto .035"	Philips Volcano AtheroMed
(510(k) #)	Thrombectomy System	System	Extraction Catheter	Phoenix 2.4mm Atherectomy
	(K193197)	(K180939)	(M20650400)	Plus System
			(K070403)	(K181877)
Classification	Class II, DXE	Class II, DXE	Class II, DXE	Class II, MCW
Regulation Description	Embolectomy Catheter	Embolectomy Catheter	Embolectomy Catheter	Catheter, Peripheral, Atherectomy
Regulation Number	870.5150 - Embolectomy	870.5150 - Embolectomy	870.5150 - Embolectomy	870.4875, Intraluminal Artery
	Catheter	Catheter	Catheter	Stripper
Classification Panel	Cardiovascular	Cardiovascular	Cardiovascular	Cardiovascular
Indications For Use	The QuickClear MechanicalThrombectomy System isintended for removal offresh, soft emboli andthrombi from vessels of theperipheral arterial andvenous systems.	INDIGO Aspiration Catheters andSeparators:As part of the INDIGO AspirationSystem, the INDIGO AspirationCatheters and Separators areindicated for the removal of fresh,soft emboli and thrombi fromvessels of the peripheral arterialand venous systems.INDIGO Aspiration Tubing:As part of the INDIGO AspirationSystem, the INDIGO SterileAspiration Tubing is indicated toconnect the INDIGO AspirationCatheters to the PenumbraAspiration Pump.	The Pronto .035"extractioncatheter is indicated for:● The removal/aspirationof embolic material(Thrombus/Debris)from vessels of thearterial system.● The removal/aspirationof embolic material(Thrombus/Debris)from vessels of thedeep venous system.● To infuse/deliverdiagnostic ortherapeutic agents.	The Phoenix Atherectomy System isintended for use in atherectomy of theperipheral vasculature. The system isnot intended for use in the coronary,carotid, iliac, pulmonary, or renalvasculature.Phoenix Atherectomy Plus System:When used with the PhoenixAspiration Pump as the vacuumsource, the Phoenix 2.4 DeflectingAtherectomy System is indicated forthe removal of thrombus from vesselsof the peripheral arterial vasculature.
		Penumbra Aspiration Pump: ThePenumbra Aspiration Pump isindicated as a vacuum source forPenumbra Aspiration Systems.
ThrombusCollection and Removal	Continuous aspiration andremoval of emboli andthrombus via a vacuumaspiration source with the	Continuous aspiration andremoval of emboli and thrombusvia a vacuum aspiration sourcewith the catheter targeted at	Removal of emboli andthrombus mechanically via a 60cc syringe based aspirationthrough the extension line and	Continuous collection and removal ofemboli and thrombus via mechanicalconveyance of
Table 5-1:Comparative Summary of QuickClear Mechanical Thrombectomy System and Predicate Devices
Attribute	Subject Device	Predicate Device	Reference Device	Direct Reference Device
Trade Name(510(k) #)	QuickClear MechanicalThrombectomy System(K193197)	Penumbra INDIGO AspirationSystem(K180939)	Teleflex Pronto .035"Extraction Catheter(M20650400)(K070403)	Philips Volcano AtheroMedPhoenix 2.4mm AtherectomyPlus System(K181877)
	catheter targeted atthrombus in the peripheralvasculature.	thrombus in the peripheralvasculature.	stopcock source with thecatheter targeted at thrombus inthe peripheral vasculature.	Catheter assisted by a vacuumaspiration source.
Basic Operating Principle/General TechnologicalDesign	Continuous aspiration andremoval of emboli andthrombus via a vacuumaspiration source with thecatheter targeted at thrombusin the peripheral vasculature.	Continuous aspiration and removalof emboli and thrombus via avacuum aspiration source with thecatheter targeted at thrombus in theperipheral vasculature.	The Pronto .035" extractioncatheter is a dual lumen, over-the-wire (OTW) catheter withrelated accessories. The catheteris designed to be deliveredthrough a 10F or largerintroducer sheath over a 0.035"guidewire. The larger lumenallows for the removal ofthrombus by use of the includedsyringe through the extensionline and stopcock. The catheterhas a rounded distal tip with aprotected, extraction lumen tofacilitate advancement of thecatheter into the blood vesseland maximize extraction ofthrombus through the extractionlumen.	Phoenix Aspiration System Pump -handheldbattery powered pumpcapable of providing avacuum source of ≥ 25inchesMercury (Hg) to aspirateblood and thrombus relatedmaterials.
	The aspiration catheteraccesses the thromboticocclusions within thevasculature and is used toaspirate material directlythrough the catheter lumen.The catheter is introducedover a guidewire (0.035") tothe site of the targetocclusion to performaspiration when connectedto the aspiration pump thatserves as a vacuum source.An obturator, supplied withthe catheter (8F & 10Fonly), may be used tofacilitate access through thevessel while providing anatraumatic transition to thefront edge of the catheter.The catheter connects to the	The aspiration catheter accesses thethrombotic occlusions within thevasculature and is used to aspiratematerial directly through thecatheter lumen.The catheter is introduced over aguidewire (0.035") to the site of thetarget occlusion to performaspiration when connected to theaspiration pump that serves as avacuum source.A separator may be deployedwithin the Aspiration Catheter toassist with thrombus removal byclearing the lumen of theAspiration Catheter should itbecome blocked with thrombus.The separator is manuallyadvanced and retracted throughthe Aspiration Catheter at theproximal margin of the primaryocclusion to facilitate clearing ofthe thrombus from the AspirationCatheter tip.	The catheter has a radiopaquemarker band locatedapproximately 4mm from thedistal tip. The proximal end ofthe catheter incorporates ahemostatic Y-junction thatallows for the attachment of thecatheter to the includedextension line, stopcock andsyringe; and can be tighteneddown on the guidewire toprevent blood leakage.
	distal end of a vacuum pumpthrough hemostasis andinline ON/OFF valve. Themale luer on the exit port ofthe vacuum pump tubingconnects to the female luer	A separator may not be necessarywhen using an Aspiration Catheterwith an ID of 0.054" (4Fr) orlarger.
Volcano Aheromed, Inc. Traditional 510(k) Premarket Notification for QuickClear Mechanical Thrombectomy System K19319 pg. 6 of 9
	on the waste collection bagtubing.Aspirated material iscollected in a wastecollection bag.Aspiration Pump - handheldbattery powered pumpcapable of providing avacuum source of ≥ 25inchMercury (Hg) to aspirateblood and thrombus relatedmaterials.	Aspirated material is collected in asuction canister.
Power Source	12V DC Battery forAspiration Pump	100-115V AC/230V AC, 50/60HZ AC Power supply forPenumbra Max Pump	N/A (manual aspiration)	12V DC Battery for PhoenixAspiration System Pump
Vacuum Source	≥ 25 inch Hg Vacuum	Up to 29 inch Hg Vacuum(electrical, piston vacuum pump)	60 ml Syringe with lockingplunger located on theextension line.	≥ 25 inch Hg Vacuum
Syringe Accessory	60cc Syringe	N/A	60cc syringe	60cc Syringe
Waste Collection Source	1400ml Waste CollectionBag	1200ml Waste Collection Canister	60cc Syringe	1400ml Waste Collection Bag
Aspiration Catheter
Aspiration Catheter OuterDiameters	6F=0.081"8F= 0.107"10F=0.130"	6F= 0.079"8F=0.105"	10F=0.128"	N/A
Tip Shape Configurations	6F - Straight8F - Straight8F - Shaped10F - Shaped	6F - Straight8F - Straight8F - Shaped	10F - rounded tip	N/A
Catheter Working Lengths	6F= 130 cm8F= 85 cm10F= 85 cm	6F= 135 cm8F= 85 cm	10F = 115 cm	N/A
Target Vessel Diameters	6F: > 3.0 mm8F: > 4.0 mm10F: > 5.0 mm	6F: > 4.0 mm8F: > 4.0 mm	10F: > 4.0 mm	N/A
GuidewireCompatibility	.035"	.035"	.035"	N/A
Obturator Outer Diameter	8F = 0.084 – 0.088"10F=0.104 – 0.108"	N/A	N/A	N/A
Tubing Inner Diameter(ID)	0.100 – 0.125"	0.071" – 0.110"	N/A	N/A
General
Materials	Polymeric blends commonlyutilized for interventionaldevices	Polymeric blends commonlyutilized for interventional devices	Polymeric blends commonlyutilized for interventionaldevices	N/A
Catheter Coating	Yes	Yes	No	N/A
Biocompatibility	Per ISO 10993-1	Per ISO 10993-1	Per ISO 10993-1	N/A pump is non patient contacting
Packaging Configuration	Catheters and pump areIndividually packaged inTyvek Pouch and chipboardboxes	Catheters are Individuallypackaged in Tyvek Pouch andchipboard boxes	Catheters are Individuallypackaged in Tyvek Pouch andchipboard boxes	Pump is individually packaged inTyvek Pouch and chipboard boxes
Sterilization	Ethylene Oxide (EO)All components	Ethylene Oxide (EO)(Catheter/separator)	Ethylene Oxide (EO)	Ethylene Oxide (EO)
Single Use Only	Catheter: YesAspiration Pump: Yes	Catheter/separator : YesVacuum Pump :(reusable/electrical)	Catheter : Yes	Catheter: YesAspiration Pump: Yes

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Testing Summary:

Since there is no change to the currently marketed Phoenix Aspiration Pump that is used as part of the subject QuickClear Mechanical Thrombectomy System (K181877), previous testing for biocompatibility, bench performance, sterilization, packaging and shelf-life, electrical safety and EMC, remain applicable and was not repeated.

To demonstrate the substantial equivalence of the subject OuickClear Mechanical Thrombectomy System to the selected predicate device, the performance and technological characteristics were evaluated by completion of the following tests:

Aspiration Catheter Tests: ●

Catheter Visual Inspection O
Catheter Dimensional Inspection O
Catheter Dry Leak Test O
o Catheter Vacuum Test
Catheter Flow Rate Test O
Catheter Tensile Test o
Catheter Torque Strength Test O
Catheter Lubricity Test O

Quick QuickClear Mechanical Thrombectomy System Test: ●

QuickClear Mechanical Thrombectomy System Simulated Use Test O

● Aspiration Catheter and Obturator Test:

Guidewire Compatibility Test for Aspiration Catheter and Obturator o
Kink Resistance Test for Aspiration Catheter and Obturator O

Obturator Test (8F and 10F Aspiration Catheter Only): ●

o Obturator Visual Inspection
O Obturator Dimensional Inspection
QuickClear vs. Predicate System Comparative Test ●
Sterilization Validation ●
Packaging and Shelf Life Tests

. Biocompatibility Tests:

The following biocompatibility tests were conducted on the QuickClear Aspiration Catheters and Obturators per ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process:

Cytotoxicity o
Sensitization O
Irritation or Intracutaneous Reactivity O

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Acute Systemic Toxicity o
Partial Thromboplastin Time (PTT) O
Material-Mediated Pyrogenicity o
Hemocompatibility O
Particulate Analysis O
In vivo Thrombogenicity O

The QuickClear Aspiration Pump is a non-patient contacting device, and therefore, biocompatibility testing was not required or conducted on the Aspiration Pump.

Preclinical Animal Testing: .

A GLP animal study was conducted to evaluate the safety and performance of the QuickClear Mechanical Thrombectomy System in an animal model. The study concluded:

o No vessel trauma
o No evidence of side effects
Minimal to no vascular injury o

Conclusion

The subject QuickClear Mechanical Thrombectomy System shares the same intended use, technological characteristics, and principles of operation with the currently marketed predicate and reference devices. The QuickClear Pump is identical to the currently cleared reference Phoenix Aspiration Pump that is part of the Phoenix 2.4 Atherectomy Plus System (K181877). The QuickClear Aspiration catheters are similar in design and construction as the predicate Penumbra Indigo Catheters. Any differences between the subject and predicate devices were evaluated through design verification and validation testing to demonstrate that the subject QuickClear Mechanical Thrombectomy System is substantially equivalent to the currently marketed predicate device.

Based on the information submitted in this 510(k) premarket notification, the subject QuickClear Mechanical Thrombectomy System is substantially equivalent to the currently marketed predicate Penumbra INDIGO Aspiration System.

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).