Device Classification Name |
Filter, Intravascular, Cardiovascular
|
510(k) Number |
K951508 |
Device Name |
STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 24F INTRODUCER SYSTEM |
Applicant |
BOSTON SCIENTIFIC CORP. |
480 PLEASANT ST. |
WATERTOWN,
MA
02472 -2407
|
|
Applicant Contact |
LAURA MONDANO |
Correspondent |
BOSTON SCIENTIFIC CORP. |
480 PLEASANT ST. |
WATERTOWN,
MA
02472 -2407
|
|
Correspondent Contact |
LAURA MONDANO |
Regulation Number | 870.3375
|
Classification Product Code |
|
Date Received | 04/03/1995 |
Decision Date | 06/22/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|