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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K885237
Device Name ACS SELECTIVE INFUSION CATHETER
Applicant
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
1395 CHARLESTON RD.
MOUNTAIN VIEW,  CA  94043
Applicant Contact KEVYN B O'CONNOR
Correspondent
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
1395 CHARLESTON RD.
MOUNTAIN VIEW,  CA  94043
Correspondent Contact KEVYN B O'CONNOR
Regulation Number870.1250
Classification Product Code
DQY  
Date Received12/21/1988
Decision Date 03/16/1989
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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