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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 K021228
Device Name HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE
Applicant
Guidant Corp.
26531 Ynez Rd.
Temecula,  CA  92591 -4630
Applicant Contact JENNIFER PAE RIGGS
Correspondent
Guidant Corp.
26531 Ynez Rd.
Temecula,  CA  92591 -4630
Correspondent Contact JENNIFER PAE RIGGS
Regulation Number870.1330
Classification Product Code
DQX  
Date Received04/18/2002
Decision Date 05/15/2002
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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