Device Classification Name |
catheter for crossing total occlusions
|
510(k) Number |
K131914 |
Device Name |
OFFROAD RE-ENTRY CATHETER SYSTEM |
Applicant |
BOSTON SCIENTIFIC CORP. |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311
|
|
Applicant Contact |
CAROL TIFFANY |
Correspondent |
BOSTON SCIENTIFIC CORP. |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311
|
|
Correspondent Contact |
CAROL TIFFANY |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 06/26/2013 |
Decision Date | 10/31/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01500031
|
Reviewed by Third Party |
No
|
Combination Product |
No
|