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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K161702
Device Name Endura guidewire
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 Number870.1330
Classification Product Code
DQX  
Date Received06/20/2016
Decision Date 12/06/2016
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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