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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 K905715
Device Name ACS ANGIOSCOPIC CATHETER
Applicant
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
3200 LAKESIDE DR.
P.O. BOX 58167
SANTA CLARA,  CA  95052 -8167
Applicant Contact JANE E BEGGS
Correspondent
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
3200 LAKESIDE DR.
P.O. BOX 58167
SANTA CLARA,  CA  95052 -8167
Correspondent Contact JANE E BEGGS
Regulation Number870.1200
Classification Product Code
DQO  
Date Received12/21/1990
Decision Date 03/18/1991
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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