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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 K861236
Device Name ACS CORONARY GUIDING CATHETER
Applicant
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
1395 CHARLESTON RD.
MOUNTAIN VIEW,  CA  94043
Applicant Contact MARIANNA FAIST
Correspondent
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
1395 CHARLESTON RD.
MOUNTAIN VIEW,  CA  94043
Correspondent Contact MARIANNA FAIST
Regulation Number870.1200
Classification Product Code
DQO  
Date Received04/02/1986
Decision Date 07/10/1986
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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