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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name introducer, catheter
510(k) Number K213492
Device Name Dib UltraNav Transseptal Catheter System
Dib UltraNav Medical, LLC
123 W. Mills Avenue STE 600
El Paso,  TX  79901
Applicant Contact Lowry Barfield
The Tamarack Group – MPLS, LLC
2584 Upton Avenue South
Minneapolis,  MN  55405
Correspondent Contact Noelle Sutton
Regulation Number870.1340
Classification Product Code
Date Received11/01/2021
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