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FDA 510(k)

Cáteter de Electrofisiologia DECANAV™ Reprocessado; Cáteter de Electrofisiologia WEBSTER® Duo-Decapolar Reprocessado

Número K: K240826 · 2024-10-11

RequerenteSterilmed, Inc.
Data da decisão2024-10-11
Código do produtoNLH
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Sterilmed, Inc.. It received FDA 510(k) clearance on 2024-10-11 under 510(k) number K240826. 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 DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter?

Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter is a medical device that received FDA 510(k) clearance on 2024-10-11. The listed applicant is Sterilmed, Inc.. The 510(k) number is K240826.

When did Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter receive FDA 510(k) clearance?

Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter received FDA 510(k) clearance on 2024-10-11, under 510(k) number K240826.

Who is the listed applicant for Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter?

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

What is the FDA product code for Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter?

The FDA product code for Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter is NLH.

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Fonte oficial

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