Device Classification Name |
catheter, continuous flush
|
510(k) Number |
K100892 |
Device Name |
RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX |
Applicant |
BOSTON SCIENTIFIC CORP. |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311 -1566
|
|
Applicant Contact |
Scott Sepple |
Correspondent |
BOSTON SCIENTIFIC CORP. |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311 -1566
|
|
Correspondent Contact |
Scott Sepple |
Regulation Number | 870.1210
|
Classification Product Code |
|
Date Received | 03/31/2010 |
Decision Date | 04/12/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|