FDA 510(k)

Swan-Ganz catheter

Número K: K233824 · 2024-06-06

Data da decisão2024-06-06

Código do produtoDYG

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Swan-Ganz catheter is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2024-06-06 under 510(k) number K233824. The device is classified under product code DYG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Swan-Ganz catheter?

Swan-Ganz catheter is a medical device that received FDA 510(k) clearance on 2024-06-06. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K233824.

When did Swan-Ganz catheter receive FDA 510(k) clearance?

Swan-Ganz catheter received FDA 510(k) clearance on 2024-06-06, under 510(k) number K233824.

Who is the listed applicant for Swan-Ganz catheter?

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

What is the FDA product code for Swan-Ganz catheter?

The FDA product code for Swan-Ganz catheter is DYG.

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Dispositivos Relacionados (Código: DYG)

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Fonte oficial

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