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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K875158
Device Name ACS FUNNEL INTRODUCER
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 Number870.1340
Classification Product Code
DYB  
Date Received12/15/1987
Decision Date 05/31/1988
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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