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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K183305
Device Name Crossing Support Catheter
Applicant
Tractus Vascular, LLC
15 Christopher Way
Eatontown,  NJ  07724
Applicant Contact Janet Burpee
Correspondent
Tractus Vascular, LLC
15 Christopher Way
Eatontown,  NJ  07724
Correspondent Contact Sam Gilbert
Regulation Number870.1250
Classification Product Code
DQY  
Date Received11/28/2018
Decision Date 08/05/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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