Device Classification Name |
Catheter, Intravascular, Diagnostic
|
510(k) Number |
K891580 |
Device Name |
INTRAVASCULAR CATHETER WITH HYDROPHILIC COATING |
Applicant |
BOSTON SCIENTIFIC CORP. |
480 PLEASANT ST. |
P.O. BOX 7407 |
WATERTOWN,
MA
02272
|
|
Applicant Contact |
ALBERT P SEPRINSKI |
Correspondent |
BOSTON SCIENTIFIC CORP. |
480 PLEASANT ST. |
P.O. BOX 7407 |
WATERTOWN,
MA
02272
|
|
Correspondent Contact |
ALBERT P SEPRINSKI |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 03/20/1989 |
Decision Date | 08/03/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|