Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K090822 |
Device Name |
ADVANCE 14RX RAPID EXCHANGE PTA BALLOON CATHETER |
Applicant |
COOK, INC. |
750 DANIELS WAY |
P.O. BOX 489 |
BLOOMINGTON,
IN
47402
|
|
Applicant Contact |
NATHAN SIMON |
Correspondent |
COOK, INC. |
750 DANIELS WAY |
P.O. BOX 489 |
BLOOMINGTON,
IN
47402
|
|
Correspondent Contact |
NATHAN SIMON |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 03/26/2009 |
Decision Date | 04/27/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|