|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
datascope system 95
|
DATASCOPE CORP.
|
K912629 |
03/11/1992
|
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
|
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
|
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/avco connector
|
DATASCOPE CORP.
|
K801601 |
01/13/1981
|
french intra-aortic 9.5 balloon on kon
|
DATASCOPE CORP.
|
K831397 |
11/02/1983
|
iabp #90 system
|
DATASCOPE CORP.
|
K831235 |
02/08/1985
|
intra aortic balloon
|
DATASCOPE CORP.
|
K893243 |
06/20/1989
|
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
|