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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 67 Results
ProductCode: DSP Applicant: DATASCOPE CORP. Decision Date To: 04/28/2024
 
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cardiosave intra-aortic balloon pump Datascope Corp. K181122 05/31/2018
cs100/cs100i intra-aortic balloon pump, cs300 intra-aortic balloon pump Datascope Corp. K172305 10/12/2017
cardiosave hybrid and rescue intra-aortic balloon pump, cardiosave li-ion battery transport and storage case Datascope Corp. K163542 01/31/2017
cardiosave hybrid intra-aortic balloon pump DATASCOPE CORP. K151254 07/02/2015
mega 8fr. 50cc and sensation plus 8fr. 50cc intra-aortic balloon catheters and accessories DATASCOPE CORP. K133074 12/12/2013
sensation plus 7.5fr. 40cc intra-aortic balloon (iab) catheter and accessories DATASCOPE CORP., CARDIAC ASSIST DIVISION K122628 09/06/2012
mega(tm) 7.5fr. 30cc intra-aortic balloon catheter and accessories, mega(tm) 7.5fr. 40cc intra-aortic balloon catheter DATASCOPE CORP., CARDIAC ASSIST DIVISION K120868 04/20/2012
datascope's 8fr. 50cc intra-aortic balloon catheter and accessories, models 0684,00-0498-01, 02 DATASCOPE CORP., CARDIAC ASSIST DIVISION K091449 06/18/2009
datascope fiber optic pressure sensor intra-aortic balloon catheter and cs300 intra-aortic balloon pump control system DATASCOPE CORP. K063525 01/05/2007
datascope 7.5fr. iab catheter and accessories DATASCOPE CORP. K041281 06/07/2004
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