FDA 510(k)

Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter

Número K: K233825 · 2024-06-07

Data da decisão2024-06-07

Código do produtoNLH

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Health. It received FDA 510(k) clearance on 2024-06-07 under 510(k) number K233825. The device is classified under product code NLH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter?

Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter is a medical device that received FDA 510(k) clearance on 2024-06-07. The listed applicant is Innovative Health. The 510(k) number is K233825.

When did Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter receive FDA 510(k) clearance?

Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter received FDA 510(k) clearance on 2024-06-07, under 510(k) number K233825.

Who is the listed applicant for Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter?

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

What is the FDA product code for Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter?

The FDA product code for Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter is NLH.

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