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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 K061453
Device Name HI-TORQUE WHISPER VIEW GUIDE WIRE
Applicant
Guidant Corp.
4100 Hamline Ave. N
St Paul,  MN  55112
Applicant Contact KATHLEEN VITTUM
Correspondent
Guidant Corp.
4100 Hamline Ave. N
St Paul,  MN  55112
Correspondent Contact KATHLEEN VITTUM
Regulation Number870.1330
Classification Product Code
DQX  
Date Received05/25/2006
Decision Date 06/22/2006
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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