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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 K990639
Device Name ACS HI-TORQUE CROSS IT 100XT, 200XT AND 300XT GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING.
Applicant
Guidant Corp.
3200 Lakeside Dr.
Santa Clara,  CA  95054
Applicant Contact MARGARET ANDERSON
Correspondent
Guidant Corp.
3200 Lakeside Dr.
Santa Clara,  CA  95054
Correspondent Contact MARGARET ANDERSON
Regulation Number870.1330
Classification Product Code
DQX  
Date Received02/26/1999
Decision Date 03/25/1999
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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