Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K052036 |
Device Name |
ATB ADVANCE PTA DILATATION CATHETER |
Applicant |
COOK, INC. |
750 DANIELS WAY |
P.O. BOX 489 |
BLOOMINGTON,
IN
47402
|
|
Applicant Contact |
KAREN BRADBURN |
Correspondent |
COOK, INC. |
750 DANIELS WAY |
P.O. BOX 489 |
BLOOMINGTON,
IN
47402
|
|
Correspondent Contact |
KAREN BRADBURN |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 07/28/2005 |
Decision Date | 08/25/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|