FDA 510(k)

Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter

Numéro K : K211806 · 2021-08-03

Date de décision2021-08-03

Code produitGEI

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Venclose, Inc.. It received FDA 510(k) clearance on 2021-08-03 under 510(k) number K211806. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter?

Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter is a medical device that received FDA 510(k) clearance on 2021-08-03. The listed applicant is Venclose, Inc.. The 510(k) number is K211806.

When did Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter receive FDA 510(k) clearance?

Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter received FDA 510(k) clearance on 2021-08-03, under 510(k) number K211806.

Who is the listed applicant for Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter?

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

What is the FDA product code for Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter?

The FDA product code for Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter is GEI.

Essais cliniques associés

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Source officielle

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