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U.S. Department of Health and Human Services

510(k) Premarket Notification

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21 to 30 of 67 Results
ProductCode: DSP Applicant: DATASCOPE CORP. Decision Date To: 04/28/2024
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pecor 8.5 french iab on a datascope DATASCOPE CORP. K831307 11/02/1983
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
modification to datascope profile 8fr. iab, 34cc; modification to datascope profile 8fr. iab, 40cc DATASCOPE CORP. K002949 10/20/2000
model 84 transport system DATASCOPE CORP. K811372 08/03/1981
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
mega 8fr. 50cc and sensation plus 8fr. 50cc intra-aortic balloon catheters and accessories DATASCOPE CORP. K133074 12/12/2013
intra-aortic balloon, type s DATASCOPE CORP. K790775 10/01/1979
intra-aortic balloon pump system 97 modified DATASCOPE CORP. K961509 11/15/1996
intra-aortic balloon for optional sheathless insertion DATASCOPE CORP. K940231 09/13/1994
intra aortic balloon DATASCOPE CORP. K893243 06/20/1989
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