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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Balloon Inflation
510(k) Number K921719
Device Name ACS ANGIOTRAK(TM) SYSTEM
Applicant
Advanced Cardiovascular Systems, Inc.
26531 Ynez Rd.
Temecula,  CA  92591
Applicant Contact KEVIN CORRIGAN
Correspondent
Advanced Cardiovascular Systems, Inc.
26531 Ynez Rd.
Temecula,  CA  92591
Correspondent Contact KEVIN CORRIGAN
Regulation Number870.1650
Classification Product Code
MAV  
Date Received04/09/1992
Decision Date 08/07/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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