Device Classification Name |
Catheter, Continuous Flush
|
510(k) Number |
K142259 |
Device Name |
Direxion Torqueable Microcatheter |
Applicant |
BOSTON SCIENTIFIC CORP. |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311
|
|
Applicant Contact |
Mark Lanz |
Correspondent |
BOSTON SCIENTIFIC CORP. |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311
|
|
Correspondent Contact |
Mark Lanz |
Regulation Number | 870.1210
|
Classification Product Code |
|
Date Received | 08/14/2014 |
Decision Date | 09/10/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|