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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 K023300
Device Name HI-TORQUE WHISPER LS; HI-TORQUE WHISPER MS; HI-TORQUE WHISPER MS CS-J; HI-TORQUE WHISPER ES; HI-TORQUE WHISPER ES CS-J
Applicant
Guidant Corp.
4100 Hamline Ave. N
St Paul,  MN  55112
Applicant Contact JANELL A COLLEY
Correspondent
Guidant Corp.
4100 Hamline Ave. N
St Paul,  MN  55112
Correspondent Contact JANELL A COLLEY
Regulation Number870.1330
Classification Product Code
DQX  
Date Received10/03/2002
Decision Date 10/28/2002
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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