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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 K992169
Device Name ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE
Applicant
Advanced Cardiovascular Systems, Inc.
3200 Lakeside Dr.
Santa Clara,  CA  95052 -8167
Applicant Contact MARGARET ANDERSON
Correspondent
Advanced Cardiovascular Systems, Inc.
3200 Lakeside Dr.
Santa Clara,  CA  95052 -8167
Correspondent Contact MARGARET ANDERSON
Regulation Number870.1330
Classification Product Code
DQX  
Date Received06/28/1999
Decision Date 10/28/1999
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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