Device Classification Name |
catheter, continuous flush
|
510(k) Number |
K132947 |
Device Name |
DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS |
Applicant |
BOSTON SCIENTIFIC CORP. |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311
|
|
Applicant Contact |
MAUREEN SUNDEEN |
Correspondent |
BOSTON SCIENTIFIC CORP. |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311
|
|
Correspondent Contact |
MAUREEN SUNDEEN |
Regulation Number | 870.1210
|
Classification Product Code |
|
Date Received | 09/19/2013 |
Decision Date | 10/18/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|