FDA 510(k)

ReVene Thrombectomy Catheter

Número K: K201705 · 2020-12-22

Data da decisão2020-12-22

Código do produtoQEW

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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