Device Classification Name |
Valvulotome
|
510(k) Number |
K924075 |
Device Name |
DISPOSABLE OPTICAL VALVULOTOME |
Applicant |
ENDOVASCULAR, INC. |
3180 PULLMAN ST. |
COSTA MESA,
CA
92626
|
|
Applicant Contact |
KAREN U SALINAS |
Correspondent |
ENDOVASCULAR, INC. |
3180 PULLMAN ST. |
COSTA MESA,
CA
92626
|
|
Correspondent Contact |
KAREN U SALINAS |
Regulation Number | 870.4885
|
Classification Product Code |
|
Date Received | 08/12/1992 |
Decision Date | 02/08/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|