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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Balloon Inflation
510(k) Number K162272
Device Name Fluent inflation device
Applicant
Vascular Solutions, Inc.
6464 Sycamore Court N
Maple Grove,  MN  55369
Applicant Contact BEKA VITE
Correspondent
Vascular Solutions, Inc.
6464 Sycamore Court N
Maple Grove,  MN  55369
Correspondent Contact BEKA VITE
Regulation Number870.1650
Classification Product Code
MAV  
Date Received08/12/2016
Decision Date 10/20/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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