Device Classification Name |
introducer, catheter
|
510(k) Number |
K142684 |
Device Name |
FlexCath Select Steerable Sheath (10 French) |
Applicant |
Medtronic CryoCath LP |
8200 Coral Sea Street NE |
Mail Stop MVS46 |
Mounds View,
MN
55112
|
|
Applicant Contact |
Vanessa Ware |
Correspondent |
Medtronic CryoCath LP |
8200 Coral Sea Street NE |
Mail Stop MVS46 |
Mounds View,
MN
55112
|
|
Correspondent Contact |
Vanessa Ware |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 09/19/2014 |
Decision Date | 11/06/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|