Device Classification Name |
Filter, Intravascular, Cardiovascular
|
510(k) Number |
K912144 |
Device Name |
SIMON NITINOL FILTER, MODIFICATION |
Applicant |
NITINOL MEDICAL TECHNOLOGIES, INC. |
101 PARK AVE. |
NEW YORK,
NY
10178
|
|
Applicant Contact |
LEONARD GORDON |
Correspondent |
NITINOL MEDICAL TECHNOLOGIES, INC. |
101 PARK AVE. |
NEW YORK,
NY
10178
|
|
Correspondent Contact |
LEONARD GORDON |
Regulation Number | 870.3375
|
Classification Product Code |
|
Date Received | 05/13/1991 |
Decision Date | 10/17/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|