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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 K884895
Device Name ACS 0.010 HI-TORQUE FLOPPY GOLD GUIDE WIRE
Original Applicant
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
1395 charleston rd.
mountain view,  CA  94043
Original Contact marianna faist
Regulation Number870.1330
Classification Product Code
DQX  
Date Received11/22/1988
Decision Date 02/06/1989
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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