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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K842195
Device Name ADVANCED CARDIOVASCULAR-CORONARY GUID
Applicant
Advanced Cardiovascular Systems, Inc.
3200 Lakeside Dr.
Santa Clara,  CA  95054
Correspondent
Advanced Cardiovascular Systems, Inc.
3200 Lakeside Dr.
Santa Clara,  CA  95054
Regulation Number870.1200
Classification Product Code
DQO  
Date Received06/04/1984
Decision Date 07/13/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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