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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 K142415
Device Name Hi-Torque JET Guide Wire Family
Applicant
Abbott Vascular, Inc.
26531 Ynez Rd.
Temecula,  CA  92591
Applicant Contact JANET BENSON
Correspondent
Abbott Vascular, Inc.
26531 Ynez Rd.
Temecula,  CA  92591
Correspondent Contact JANET BENSON
Regulation Number870.1330
Classification Product Code
DQX  
Date Received08/28/2014
Decision Date 12/19/2014
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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