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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 K822862
Device Name BRACHIAL CORONARY GUIDING CATHETER
Applicant
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
3200 LAKESIDE DR.
SANTA CLARA,  CA  95054 -2807
Correspondent
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
3200 LAKESIDE DR.
SANTA CLARA,  CA  95054 -2807
Regulation Number870.1200
Classification Product Code
DQO  
Date Received09/27/1982
Decision Date 10/18/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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