FDA 510(k)

XTRA Autotransfusion System (with XTRA Bowl sets)

Número K: K240584 · 2024-04-29

Data da decisão2024-04-29

Código do produtoCAC

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

XTRA Autotransfusion System (with XTRA Bowl sets) is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2024-04-29 under 510(k) number K240584. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the XTRA Autotransfusion System (with XTRA Bowl sets)?

XTRA Autotransfusion System (with XTRA Bowl sets) is a medical device that received FDA 510(k) clearance on 2024-04-29. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K240584.

When did XTRA Autotransfusion System (with XTRA Bowl sets) receive FDA 510(k) clearance?

XTRA Autotransfusion System (with XTRA Bowl sets) received FDA 510(k) clearance on 2024-04-29, under 510(k) number K240584.

Who is the listed applicant for XTRA Autotransfusion System (with XTRA Bowl sets)?

The FDA 510(k) record lists Sorin Group Italia S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XTRA Autotransfusion System (with XTRA Bowl sets)?

The FDA product code for XTRA Autotransfusion System (with XTRA Bowl sets) is CAC.

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Fonte oficial

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