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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter for crossing total occlusions
510(k) Number K221163
Device Name Tunnel Crossing Catheter
Applicant
Tractus Vascular, LLC
20 Meridian Road
Unit 9B
Eatontown,  NJ  07724
Applicant Contact Janet Burpee
Correspondent
Tractus Vascular, LLC
20 Meridian Road
Unit 9B
Eatontown,  NJ  07724
Correspondent Contact Janet Burpee
Regulation Number870.1250
Classification Product Code
PDU  
Date Received04/22/2022
Decision Date 01/19/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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