Device Classification Name |
catheter, angioplasty, peripheral, transluminal
|
510(k) Number |
K953608 |
Device Name |
NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER |
Applicant |
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. |
112 BAUER DR. |
OAKLAND,
NJ
07436
|
|
Applicant Contact |
STEPHEN B ANDERSON |
Correspondent |
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. |
112 BAUER DR. |
OAKLAND,
NJ
07436
|
|
Correspondent Contact |
STEPHEN B ANDERSON |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 08/02/1995 |
Decision Date | 12/20/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|