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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 K060449
Device Name HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE
Applicant
GUIDANT CORPORATION
26531 YNEZ ROAD
TEMECULA,  CA  92591
Applicant Contact JENNIFER PAE RIGGS
Correspondent
GUIDANT CORPORATION
26531 YNEZ ROAD
TEMECULA,  CA  92591
Correspondent Contact JENNIFER PAE RIGGS
Regulation Number870.1330
Classification Product Code
DQX  
Date Received02/21/2006
Decision Date 05/30/2006
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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