Device Classification Name |
filter, intravascular, cardiovascular
|
510(k) Number |
K940489 |
Device Name |
SIMON NITINOL FILTER |
Applicant |
NITINOL MEDICAL TECHNOLOGIES, INC. |
374 CONGRESS STREET, SUITE 605 |
BOSTON,
MA
02210
|
|
Applicant Contact |
STEPHEN J KLESHINSKI |
Correspondent |
NITINOL MEDICAL TECHNOLOGIES, INC. |
374 CONGRESS STREET, SUITE 605 |
BOSTON,
MA
02210
|
|
Correspondent Contact |
STEPHEN J KLESHINSKI |
Regulation Number | 870.3375
|
Classification Product Code |
|
Date Received | 01/25/1994 |
Decision Date | 08/09/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|