FDA 510(k)

SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter

Número K: K201377 · 2020-10-09

Data da decisão2020-10-09

Código do produtoLIT

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corporation. It received FDA 510(k) clearance on 2020-10-09 under 510(k) number K201377. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter?

SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2020-10-09. The listed applicant is Cordis Corporation. The 510(k) number is K201377.

When did SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter receive FDA 510(k) clearance?

SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter received FDA 510(k) clearance on 2020-10-09, under 510(k) number K201377.

Who is the listed applicant for SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter?

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

What is the FDA product code for SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter?

The FDA product code for SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter is LIT.

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Outros registros que listam Cordis Corporation como candidato(a)

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Fonte oficial

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