FDA 510(k)

NuVision ICE Catheter

Número K: K201775 · 2021-03-05

Data da decisão2021-03-05

Código do produtoOBJ

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

NuVision ICE Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Nuvera Medical, Inc.. It received FDA 510(k) clearance on 2021-03-05 under 510(k) number K201775. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the NuVision ICE Catheter?

NuVision ICE Catheter is a medical device that received FDA 510(k) clearance on 2021-03-05. The listed applicant is Nuvera Medical, Inc.. The 510(k) number is K201775.

When did NuVision ICE Catheter receive FDA 510(k) clearance?

NuVision ICE Catheter received FDA 510(k) clearance on 2021-03-05, under 510(k) number K201775.

Who is the listed applicant for NuVision ICE Catheter?

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

What is the FDA product code for NuVision ICE Catheter?

The FDA product code for NuVision ICE Catheter is OBJ.

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