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U.S. Department of Health and Human Services

510(k) Premarket Notification

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11 to 20 of 67 Results
ProductCode: DSP Applicant: Datascope Corp. Decision Date To: 06/29/2022
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cs100 intra-aortic balloon pump, model 0998-00-3013-xx DATASCOPE CORP. K031636 08/11/2003
datascope ca 40 8fr. iabs, model 0684-00-04xx DATASCOPE CORP. K031569 06/10/2003
datascope's 8fr. alt b iab; datascope's profile 8fr. alt b iab; datascope's true sheathless dl 9.5 fr. iab; datascope's DATASCOPE CORP. K020257 04/24/2002
modification to: datascope 8fr. polyimide alt b iab, 25cc, 34cc, 40cc, datascope insertion kit for 8 fr, polyimide alt b DATASCOPE CORP. K013326 11/02/2001
datascope profile 8fr. alt b iab, 34cc, datascope profile 8fr. alt b iab, 40cc, model 0684-000319, 0684-00-0320 DATASCOPE CORP. K003598 12/21/2000
modification to datascope profile 8fr. iab, 34cc; modification to datascope profile 8fr. iab, 40cc DATASCOPE CORP. K002949 10/20/2000
datascope's 8fr. polymide 25cc,34cc and 40cc iab and accessories, models 0684-00-0327, 06844-00-0328, 0684-00-0329 DATASCOPE CORP. K994157 03/13/2000
datascope percor stat-dl 9.5 fr. 25, 34 and 40cc intra-aoric balloons with alternate b membrane for optional sheathles DATASCOPE CORP. K980780 05/29/1998
datascope 8fr. co-lumen 34 and 40cc intra-aortic balloon catheters for optional sheathless insertion with accessories DATASCOPE CORP. K980385 05/01/1998
system 96 intra-aortic balloon pump (iabp) DATASCOPE CORP. K965236 07/01/1997
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