FDA 510(k)

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

Número K: K163542 · 2017-01-31

Data da decisão2017-01-31

Código do produtoDSP

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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Outros registros que listam Datascope Corp. como candidato(a)

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)

K250542Bomba Balão Intra-Aórtico da Série AC3 RangeArrow International, LLC K232343Bomba Balão Intra-Aórtico da Série AC3Arrow International, LLC K201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow International, Inc.K200634Arrow FiberOptix Intra-Aortic Balloon Catheter KitArrow International, Inc.K192238Bomba Balão Intra-Aórtico da Série AC3Arrow International, Teleflex K190101UltraFlex IABArrow International, Inc.

Fonte oficial

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