FDA 510(k)

Seclusion Catheter

Número K: K243436 · 2025-02-28

Data da decisão2025-02-28

Código do produtoDQY

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Seclusion Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Basis Medical. It received FDA 510(k) clearance on 2025-02-28 under 510(k) number K243436. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Seclusion Catheter?

Seclusion Catheter is a medical device that received FDA 510(k) clearance on 2025-02-28. The listed applicant is Basis Medical. The 510(k) number is K243436.

When did Seclusion Catheter receive FDA 510(k) clearance?

Seclusion Catheter received FDA 510(k) clearance on 2025-02-28, under 510(k) number K243436.

Who is the listed applicant for Seclusion Catheter?

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

What is the FDA product code for Seclusion Catheter?

The FDA product code for Seclusion Catheter is DQY.

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Fonte oficial

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