FDA 510(k)

CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case

N.º K: K163542 · 2017-01-31

Fecha de decisión2017-01-31

Código de productoDSP

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case is the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp.. It received FDA 510(k) clearance on 2017-01-31 under 510(k) number K163542. The device is classified under product code DSP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case?

CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case is a medical device that received FDA 510(k) clearance on 2017-01-31. The listed applicant is Datascope Corp.. The 510(k) number is K163542.

When did CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case receive FDA 510(k) clearance?

CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case received FDA 510(k) clearance on 2017-01-31, under 510(k) number K163542.

Who is the listed applicant for CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case?

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

What is the FDA product code for CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case?

The FDA product code for CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case is DSP.

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Otros registros que enlistan a Datascope Corp. como solicitante

K190884TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool K181122CARDIOSAVE Intra-Aortic Balloon Pump K172305CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump

Dispositivos relacionados (Código: DSP)

K250542AC3® Range® Intra-Aortic Balloon PumpArrow International, LLC K232343AC3® Series IABPArrow International, LLC K201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow International, Inc.K200634Kit de Catéter Balón Intra-Aórtico FiberOptix ArrowArrow International, Inc.K192238AC3 Series Intra-Aortic Balloon Pump (IABP)Arrow International, Teleflex K190101UltraFlex IABArrow International, Inc.

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.