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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 K860580
Device Name ACS BRACHIAL CORONARY GUIDING CATH W/TAPERED TIP
Original Applicant
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
1395 charleston rd.
mountain view,  CA  94043
Original Contact jane e beggs
Regulation Number870.1200
Classification Product Code
DQO  
Date Received02/18/1986
Decision Date 03/31/1986
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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