Device Classification Name |
catheter, angioplasty, peripheral, transluminal
|
510(k) Number |
K833616 |
Device Name |
OLBERT CATHETER SYSTEM |
Applicant |
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 10/13/1983 |
Decision Date | 12/26/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|