Device Classification Name |
Catheter, Angioplasty, Peripheral, Transluminal
|
510(k) Number |
K913689 |
Device Name |
SUB-4(TM), PERIPHERAL DILATATION CATHETER |
Applicant |
BOSTON SCIENTIFIC CORP. |
2710 ORCHARD PKWY. |
SAN JOSE,
CA
95134
|
|
Applicant Contact |
STEPHEN M PAGE |
Correspondent |
BOSTON SCIENTIFIC CORP. |
2710 ORCHARD PKWY. |
SAN JOSE,
CA
95134
|
|
Correspondent Contact |
STEPHEN M PAGE |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 08/19/1991 |
Decision Date | 10/16/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|