|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
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
|
8 fr.-40cc arrow flex intra-aortic balloon catheter with blue flex tip, product number iab-04840(used with a 9fr.sheath)
|
ARROW INTL., INC.
|
K960713 |
05/15/1996
|
8fr. narrowflex universal intra-aortic balloon catheter
|
ARROW INTL., INC.
|
K993966 |
02/18/2000
|
9.5 fr.- flexi-cath intra-aortic and control system
|
ARROW INTL., INC.
|
K963104 |
02/04/1997
|
acat 1 (arrow cardiac assist technology 1)
|
ARROW INTL., INC.
|
K965209 |
01/23/1998
|
arrow acat 2 intra-aortic balloon pump
|
ARROW INTL., INC.
|
K002256 |
05/03/2001
|
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 kink resistant flexi-cath intra-aortic balloon
|
ARROW INTL., INC.
|
K945230 |
05/09/1995
|
arrow rediguard, 9fr. 50cc, intra-aortic balloon vatheter, iab-r950-u
|
ARROW INTL., INC.
|
K010330 |
03/02/2001
|
|