FDA 510(k)

Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)

N.º K: K221722 · 2022-11-15

Fecha de decisión2022-11-15

Código de productoCAC

Comité asesorAN

DecisiónSubstantially Equivalent

Resumen del dispositivo

Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) is the device name listed in this FDA 510(k) record. The listed applicant is Haemonetics Corporation. It received FDA 510(k) clearance on 2022-11-15 under 510(k) number K221722. 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 Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)?

Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) is a medical device that received FDA 510(k) clearance on 2022-11-15. The listed applicant is Haemonetics Corporation. The 510(k) number is K221722.

When did Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) receive FDA 510(k) clearance?

Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) received FDA 510(k) clearance on 2022-11-15, under 510(k) number K221722.

Who is the listed applicant for Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)?

The FDA 510(k) record lists Haemonetics Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)?

The FDA product code for Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) is CAC.

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Otros registros que enlistan a Haemonetics Corporation como solicitante

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Dispositivos relacionados (Código: CAC)

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Fuente oficial

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