Device Classification Name |
Catheter, Angioplasty, Peripheral, Transluminal
|
510(k) Number |
K972800 |
Device Name |
PTA BALLOON CATHETER |
Applicant |
COOK, INC. |
925 SOUTH CURRY PIKE |
P.O. BOX 489 |
BLOOMINGTON,
IN
47402
|
|
Applicant Contact |
APRIL LAVENDER |
Correspondent |
COOK, INC. |
925 SOUTH CURRY PIKE |
P.O. BOX 489 |
BLOOMINGTON,
IN
47402
|
|
Correspondent Contact |
APRIL LAVENDER |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 07/28/1997 |
Decision Date | 04/16/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|