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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
Original Applicant
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 (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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