Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K032931 |
Device Name |
PTA BALLOON CATHETER |
Applicant |
COOK, INC. |
750 DANIELS WAY |
P.O. BOX 489 |
BLOOMINGTON,
IN
47402 -0489
|
|
Applicant Contact |
KAREN BRADBURN |
Correspondent |
COOK, INC. |
750 DANIELS WAY |
P.O. BOX 489 |
BLOOMINGTON,
IN
47402 -0489
|
|
Correspondent Contact |
KAREN BRADBURN |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 09/22/2003 |
Decision Date | 10/22/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|