FDA 510(k)

Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)

N.º K: K160754 · 2016-09-09

Fecha de decisión2016-09-09

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Venclose Radiofrequency System (digiRF Generator, EVSRF 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 2016-09-09 under 510(k) number K160754. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)?

Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) is a medical device that received FDA 510(k) clearance on 2016-09-09. The listed applicant is Venclose, Inc.. The 510(k) number is K160754.

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

Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) received FDA 510(k) clearance on 2016-09-09, under 510(k) number K160754.

Who is the listed applicant for Venclose Radiofrequency System (digiRF Generator, EVSRF 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 Radiofrequency System (digiRF Generator, EVSRF Catheter)?

The FDA product code for Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) is GEI.

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Otros registros que enlistan a Venclose, Inc. como solicitante

K252316Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)K250068Venclose digiRF Generator (VCRFG1)K211806Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter

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Fuente oficial

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