Device Classification Name |
introducer, catheter
|
510(k) Number |
K213492 |
Device Name |
Dib UltraNav Transseptal Catheter System |
Applicant |
Dib UltraNav Medical, LLC |
123 W. Mills Avenue STE 600 |
El Paso,
TX
79901
|
|
Applicant Contact |
Lowry Barfield |
Correspondent |
The Tamarack Group – MPLS, LLC |
2584 Upton Avenue South |
Minneapolis,
MN
55405
|
|
Correspondent Contact |
Noelle Sutton |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 11/01/2021 |
Decision Date | 03/24/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|