Device Classification Name |
Catheter, Intravascular, Diagnostic
|
510(k) Number |
K895542 |
Device Name |
SONICATH(TM) 5 F |
Applicant |
BOSTON SCIENTIFIC CORP. |
480 PLEASANT ST. |
P.O. BOX 7407 |
WATERTOWN,
MA
02272
|
|
Applicant Contact |
ALFRED COUVILLON |
Correspondent |
BOSTON SCIENTIFIC CORP. |
480 PLEASANT ST. |
P.O. BOX 7407 |
WATERTOWN,
MA
02272
|
|
Correspondent Contact |
ALFRED COUVILLON |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 09/13/1989 |
Decision Date | 04/06/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|