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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 K896379
Device Name ACS GOLD SERIES ELASTINITE GUIDE WIRE
Applicant
Advanced Cardiovascular Systems, Inc.
3200 Lakeside Dr.
P.O. Box 58167
Santa Clara,  CA  95052
Applicant Contact MICHAEL C KOLBER
Correspondent
Advanced Cardiovascular Systems, Inc.
3200 Lakeside Dr.
P.O. Box 58167
Santa Clara,  CA  95052
Correspondent Contact MICHAEL C KOLBER
Regulation Number870.1330
Classification Product Code
DQX  
Date Received11/06/1989
Decision Date 02/02/1990
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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