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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 K973494
Device Name HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDG
Applicant
GUIDANT CORP.
3200 LAKESIDE DR.
P.O. BOX 58167
SANTA CLARA,  CA  95052 -8167
Applicant Contact MARGARET ANDERSON
Correspondent
GUIDANT CORP.
3200 LAKESIDE DR.
P.O. BOX 58167
SANTA CLARA,  CA  95052 -8167
Correspondent Contact MARGARET ANDERSON
Regulation Number870.1330
Classification Product Code
DQX  
Date Received09/15/1997
Decision Date 12/12/1997
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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