FDA 510(k)

ReVene Thrombectomy Catheter

Numéro K : K201705 · 2020-12-22

Date de décision2020-12-22

Code produitQEW

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : QEW)

K253419Triever Duo CatheterInari Medical, Inc.K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering K262538Artix™ MT;Artix™ Thin-Walled SheathInari Medical, Inc.K261523Vertex™ Thrombectomy SystemJupiter Endovascular K260599INDIGO® Aspiration System – INDIGO LinkPenumbra, Inc.K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKPenumbra, Inc.

Source officielle

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