Device Classification Name |
catheter, angioplasty, peripheral, transluminal
|
510(k) Number |
K893411 |
Device Name |
STEALTH DILATION CATHETER SYSTEM |
Applicant |
TARGET THERAPEUTICS |
130 RIO ROBLES |
P.O. BOX 610458 |
SAN JOSE,
CA
95134
|
|
Applicant Contact |
MARIE DANIELS |
Correspondent |
TARGET THERAPEUTICS |
130 RIO ROBLES |
P.O. BOX 610458 |
SAN JOSE,
CA
95134
|
|
Correspondent Contact |
MARIE DANIELS |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 05/02/1989 |
Decision Date | 09/05/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|