|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
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
|
balloon pump
|
DATASCOPE CORP.
|
K780280 |
03/15/1978
|
cardiosave hybrid and rescue intra-aortic balloon pump, cardiosave li-ion battery transport and storage case
|
Datascope Corp.
|
K163542 |
01/31/2017
|
cardiosave hybrid intra-aortic balloon pump
|
DATASCOPE CORP.
|
K151254 |
07/02/2015
|
cardiosave intra-aortic balloon pump
|
Datascope Corp.
|
K181122 |
05/31/2018
|
cs100 intra-aortic balloon pump, model 0998-00-3013-xx
|
DATASCOPE CORP.
|
K031636 |
08/11/2003
|
cs100/cs100i intra-aortic balloon pump, cs300 intra-aortic balloon pump
|
Datascope Corp.
|
K172305 |
10/12/2017
|
datascope 10.5 french intra-aortic bal
|
DATASCOPE CORP.
|
K821065 |
08/19/1982
|