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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K881787
Device Name ACS HI-TORQUE STANDARD & INTERMEDI. GUIDE WIRE
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 Number870.1330
Classification Product Code
DQX  
Date Received04/26/1988
Decision Date 07/25/1988
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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