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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 K031678
Device Name HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
Applicant
Guidant Corp.
26531 Ynez Rd.
Temecula,  CA  92591
Applicant Contact BRUCE CERWIN
Correspondent
Guidant Corp.
26531 Ynez Rd.
Temecula,  CA  92591
Correspondent Contact BRUCE CERWIN
Regulation Number870.1330
Classification Product Code
DQX  
Date Received05/30/2003
Decision Date 08/26/2003
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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