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Device Name
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Applicant
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510(K) Number
|
Decision Date
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cs100 intra-aortic balloon pump, model 0998-00-3013-xx
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DATASCOPE CORP.
|
K031636 |
08/11/2003
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datascope ca 40 8fr. iabs, model 0684-00-04xx
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DATASCOPE CORP.
|
K031569 |
06/10/2003
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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
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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
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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
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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
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datascope 8fr. co-lumen 34 and 40cc intra-aortic balloon catheters for optional sheathless insertion with accessories
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DATASCOPE CORP.
|
K980385 |
05/01/1998
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system 96 intra-aortic balloon pump (iabp)
|
DATASCOPE CORP.
|
K965236 |
07/01/1997
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