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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
Original Applicant
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
3200 lakeside dr.
p.o. box 58167
santa clara,  CA  95052 8167
Original Contact jane e beggs
Regulation Number870.1200
Classification Product Code
DQO  
Date Received12/21/1990
Decision Date 03/18/1991
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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