|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
system 90 intra-aortic balloon pump console
|
DATASCOPE CORP.
|
K921638 |
02/10/1993
|
system 90 transport
|
DATASCOPE CORP.
|
K863219 |
01/14/1987
|
system 96 intra-aortic balloon pump (iabp)
|
DATASCOPE CORP.
|
K965236 |
07/01/1997
|
system 97
|
DATASCOPE CORP.
|
K922235 |
04/27/1993
|
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
|
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
|
sensation plus 7.5fr. 40cc intra-aortic balloon (iab) catheter and accessories
|
DATASCOPE CORP., CARDIAC ASSIST DIVISION
|
K122628 |
09/06/2012
|