FDA 510(k)

XTRA Collection sets; XTRA Sequestration set X

Número K: K241236 · 2024-08-16

Data da decisão2024-08-16

Código do produtoCAC

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

XTRA Collection sets; XTRA Sequestration set X 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 2024-08-16 under 510(k) number K241236. 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 Collection sets; XTRA Sequestration set X?

XTRA Collection sets; XTRA Sequestration set X is a medical device that received FDA 510(k) clearance on 2024-08-16. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K241236.

When did XTRA Collection sets; XTRA Sequestration set X receive FDA 510(k) clearance?

XTRA Collection sets; XTRA Sequestration set X received FDA 510(k) clearance on 2024-08-16, under 510(k) number K241236.

Who is the listed applicant for XTRA Collection sets; XTRA Sequestration set X?

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 Collection sets; XTRA Sequestration set X?

The FDA product code for XTRA Collection sets; XTRA Sequestration set X is CAC.

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Fonte oficial

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