Device Classification Name |
System, Balloon, Intra-Aortic And Control
|
510(k) Number |
K963865 |
Device Name |
8 FR. -30CC NARROWFLEX SHEATHLESS INTRA-AORTIC BALLOON CATHETER, PRODUCT NUMBER IAB-04830S |
Applicant |
ARROW INTL., INC. |
3000 BERNVILLE RD. |
READING,
PA
19605
|
|
Applicant Contact |
THOMAS D NICKEL |
Correspondent |
ARROW INTL., INC. |
3000 BERNVILLE RD. |
READING,
PA
19605
|
|
Correspondent Contact |
THOMAS D NICKEL |
Regulation Number | 870.3535
|
Classification Product Code |
|
Date Received | 09/24/1996 |
Decision Date | 09/16/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|