Device Classification Name |
catheter, steerable
|
510(k) Number |
K202620 |
Device Name |
FlexCath Advance Steerable Sheath and Dilator |
Applicant |
Medtronic CryoCath LP |
8200 Coral Sea Street NE, MVS 46 |
Mounds View,
MN
55112
|
|
Applicant Contact |
Matthew Lobeck |
Correspondent |
Medtronic CryoCath LP |
8200 Coral Sea Street NE, MVS 46 |
Mounds View,
MN
55112
|
|
Correspondent Contact |
Matthew Lobeck |
Regulation Number | 870.1280
|
Classification Product Code |
|
Date Received | 09/10/2020 |
Decision Date | 11/13/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|