|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
autocat intra-aortic balloon pump series
|
ARROW INTL., INC.
|
K060309 |
04/06/2006
|
intra-aortic balloon (iab)
|
ARROW INTL., INC.
|
K040801 |
05/06/2004
|
arrow intra-aortic balloon (iab) catheter with a fiber optic sensor and a measurement system, models iab-05830-f,iab5840
|
ARROW INTL., INC.
|
K021462 |
06/06/2002
|
arrow rediguard, 9fr. 50cc, intra-aortic balloon vatheter, iab-r950-u
|
ARROW INTL., INC.
|
K010330 |
03/02/2001
|
arrow acat 2 intra-aortic balloon pump
|
ARROW INTL., INC.
|
K002256 |
05/03/2001
|
arrow ultra 8 intra-aortic balloon catheters (iabs) 8fr 30cc and 40cc universal
|
ARROW INTL., INC.
|
K000729 |
05/19/2000
|
8fr. narrowflex universal intra-aortic balloon catheter
|
ARROW INTL., INC.
|
K993966 |
02/18/2000
|
iab-04840-u;iab-04250-u;iab-04240-u;iab-04230-u
|
ARROW INTL., INC.
|
K970689 |
06/04/1998
|
8 fr. -30cc narrowflex sheathless intra-aortic balloon catheter, product number iab-04830s
|
ARROW INTL., INC.
|
K963865 |
09/16/1997
|
8 fr.-30cc narrowflex intra-aortic balloon catheter,
|
ARROW INTL., INC.
|
K963920 |
06/17/1997
|
|