FDA 510(k)

XTRA Autotransfusion System (with XTRA Bowl sets)

N.º K: K240584 · 2024-04-29

Fecha de decisión2024-04-29

Código de productoCAC

Comité asesorAN

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Ver todos los 24 dispositivos →

Dispositivos relacionados (Código: CAC)

K241236XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L.K240426Aventus Clot Management SystemInquis Medical K231782FlowSaver Blood Return System (80-101)Inari Medical, Inc.K221483FlowSaver Blood Return SystemInari Medical, Inc.K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)Haemonetics Corporation K201305Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest DrainAtrium Medical Corporation

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.