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FDA 510(k)

ReVene Thrombectomy Catheter

K-Number: K201705 · 2020-12-22

ApplicantVetex Medical, Ltd.
Decision Date2020-12-22
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ReVene Thrombectomy Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Vetex Medical, Ltd.. It received FDA 510(k) clearance on 2020-12-22 under 510(k) number K201705. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ReVene Thrombectomy Catheter?

ReVene Thrombectomy Catheter is a medical device that received FDA 510(k) clearance on 2020-12-22. The listed applicant is Vetex Medical, Ltd.. The 510(k) number is K201705.

When did ReVene Thrombectomy Catheter receive FDA 510(k) clearance?

ReVene Thrombectomy Catheter received FDA 510(k) clearance on 2020-12-22, under 510(k) number K201705.

Who is the listed applicant for ReVene Thrombectomy Catheter?

The FDA 510(k) record lists Vetex Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ReVene Thrombectomy Catheter?

The FDA product code for ReVene Thrombectomy Catheter is QEW.

Related Devices (Code: QEW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261523Vertex™ Thrombectomy SystemJupiter EndovascularK260599INDIGO® Aspiration System – INDIGO LinkPenumbra, Inc.K260028CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration CanisterArgon Medical Devices, Inc.K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKPenumbra, Inc.K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.K251207Sangria™ Thrombectomy SystemAvantec Vascular Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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