FDA 510(k)

VenaPro Vascular Therapy System

Número K: K193020 · 2019-12-04

Data da decisão2019-12-04

Código do produtoJOW

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

VenaPro Vascular Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Innovamed Health, LLC. It received FDA 510(k) clearance on 2019-12-04 under 510(k) number K193020. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VenaPro Vascular Therapy System?

VenaPro Vascular Therapy System is a medical device that received FDA 510(k) clearance on 2019-12-04. The listed applicant is Innovamed Health, LLC. The 510(k) number is K193020.

When did VenaPro Vascular Therapy System receive FDA 510(k) clearance?

VenaPro Vascular Therapy System received FDA 510(k) clearance on 2019-12-04, under 510(k) number K193020.

Who is the listed applicant for VenaPro Vascular Therapy System?

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

What is the FDA product code for VenaPro Vascular Therapy System?

The FDA product code for VenaPro Vascular Therapy System is JOW.

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