Device Classification Name |
catheter, angioplasty, peripheral, transluminal
|
510(k) Number |
K870215 |
Device Name |
DOTTER BALLOON TRANSLUMINAL ANGIO. CATHETER (POLY) |
Applicant |
COOK, INC. |
925 SOUTH CURRY PIKE |
P.O. BOX 489 |
BLOOMINGTON,
IN
47402
|
|
Applicant Contact |
DEXTER J ELKINS |
Correspondent |
COOK, INC. |
925 SOUTH CURRY PIKE |
P.O. BOX 489 |
BLOOMINGTON,
IN
47402
|
|
Correspondent Contact |
DEXTER J ELKINS |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 01/20/1987 |
Decision Date | 08/12/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|