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FDA 510(k)

Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform

Número K: K231248 · 2023-09-21

RequerenteEdwards Lifesciencess, LLC
Data da decisão2023-09-21
Código do produtoDYG
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciencess, LLC. It received FDA 510(k) clearance on 2023-09-21 under 510(k) number K231248. 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 Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform?

Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform is a medical device that received FDA 510(k) clearance on 2023-09-21. The listed applicant is Edwards Lifesciencess, LLC. The 510(k) number is K231248.

When did Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform receive FDA 510(k) clearance?

Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform received FDA 510(k) clearance on 2023-09-21, under 510(k) number K231248.

Who is the listed applicant for Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform?

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

What is the FDA product code for Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform?

The FDA product code for Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform is DYG.

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