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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 K021285
Device Name HI-TORQUE EXTRA S'PORT GUIDEWIRE
Applicant
Guidant Corp.
4100 Hamline Ave., N.
St. Paul,  MN  55112 -5798
Applicant Contact KAREN S ALSOP
Correspondent
Guidant Corp.
4100 Hamline Ave., N.
St. Paul,  MN  55112 -5798
Correspondent Contact KAREN S ALSOP
Regulation Number870.1330
Classification Product Code
DQX  
Date Received04/18/2002
Decision Date 05/02/2002
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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