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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 K161901
Device Name TrapLiner catheter
Applicant
Vascular Solutions, Inc.
6464 Sycamore Court North
Minneapolis,  MN  55369
Applicant Contact Beka Vite
Correspondent
Vascular Solutions, Inc.
6464 Sycamore Court North
Minneapolis,  MN  55369
Correspondent Contact Beka Vite
Regulation Number870.1250
Classification Product Code
DQY  
Date Received07/11/2016
Decision Date 02/03/2017
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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