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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 K950752
Device Name ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS
Applicant
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
26351 YNEZ RD.
TEMECULA,  CA  92591 -4628
Applicant Contact KEVIN CORRIGAN
Correspondent
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
26351 YNEZ RD.
TEMECULA,  CA  92591 -4628
Correspondent Contact KEVIN CORRIGAN
Regulation Number870.1330
Classification Product Code
DQX  
Subsequent Product Code
DYB  
Date Received02/17/1995
Decision Date 05/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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