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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 K915723
Device Name .10' HI-TORQUE FLOPPY, INTER. & STAND. GUIDE WIRE
Applicant
Advanced Cardiovascular Systems, Inc.
3200 Lakeside Dr.
P.O. Box 58167
Santa Clara,  CA  95052
Applicant Contact JANE BEGGS
Correspondent
Advanced Cardiovascular Systems, Inc.
3200 Lakeside Dr.
P.O. Box 58167
Santa Clara,  CA  95052
Correspondent Contact JANE BEGGS
Regulation Number870.1330
Classification Product Code
DQX  
Date Received12/20/1991
Decision Date 06/09/1992
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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