Device Classification Name |
catheter, steerable
|
510(k) Number |
K232321 |
Device Name |
FlexCath Contour™ Steerable Sheath |
Applicant |
Medtronic Inc. |
8200 Coral Sea Street NE |
Mounds View,
MN
55112
|
|
Applicant Contact |
Kripa Pandya |
Correspondent |
Medtronic Inc. |
8200 Coral Sea Street NE |
Mounds View,
MN
55112
|
|
Correspondent Contact |
Kripa Pandya |
Regulation Number | 870.1280
|
Classification Product Code |
|
Date Received | 08/03/2023 |
Decision Date | 10/31/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|