Device Classification Name |
Filter, Intravascular, Cardiovascular
|
510(k) Number |
K944353 |
Device Name |
SIMON NITINOL FILTER |
Applicant |
NITINOL MEDICAL TECHNOLOGIES, INC. |
555 THIRTEENTH STREET, N.W. |
WASHINGTON,
DC
20004 -1109
|
|
Applicant Contact |
JONATHAN S KAHAN |
Correspondent |
NITINOL MEDICAL TECHNOLOGIES, INC. |
555 THIRTEENTH STREET, N.W. |
WASHINGTON,
DC
20004 -1109
|
|
Correspondent Contact |
JONATHAN S KAHAN |
Regulation Number | 870.3375
|
Classification Product Code |
|
Date Received | 08/30/1994 |
Decision Date | 04/28/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|