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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 K911957
Device Name ACS RX SUPPORT CATHETER
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 Number870.1200
Classification Product Code
DQO  
Date Received05/02/1991
Decision Date 09/06/1991
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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