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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 K083706
Device Name HI-TORQUE VERSACORE GUIDE WIRE
Applicant
Abbott Vascular
3200 Lakeside Dr.
S,Mta Clara,  CA  95054
Applicant Contact NADINE SMITH
Correspondent
Abbott Vascular
3200 Lakeside Dr.
S,Mta Clara,  CA  95054
Correspondent Contact NADINE SMITH
Regulation Number870.1330
Classification Product Code
DQX  
Date Received12/15/2008
Decision Date 02/06/2009
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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