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U.S. Department of Health and Human Services

510(k) Premarket Notification

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41 to 50 of 67 Results
ProductCode: DSP Applicant: Datascope Corp. Decision Date To: 06/29/2022
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intra-aortic balloon for optional sheathless insertion DATASCOPE CORP. K940231 09/13/1994
intra-aortic balloon pump system 97 modified DATASCOPE CORP. K961509 11/15/1996
intra-aortic balloon, type s DATASCOPE CORP. K790775 10/01/1979
mega 8fr. 50cc and sensation plus 8fr. 50cc intra-aortic balloon catheters and accessories DATASCOPE CORP. K133074 12/12/2013
model 84 transport system DATASCOPE CORP. K811372 08/03/1981
modification to datascope profile 8fr. iab, 34cc; modification to datascope profile 8fr. iab, 40cc DATASCOPE CORP. K002949 10/20/2000
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
pecor 8.5 french iab on a datascope DATASCOPE CORP. K831307 11/02/1983
pecor, percor-dl, 10.5 french w/smec DATASCOPE CORP. K820882 10/18/1982
pediatric intra-aortic balloon catheters DATASCOPE CORP. K905663 08/02/1993
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