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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 K914828
Device Name 010 HI-TOR INTER/STAND GUIDWIRE PRESHAPE TIP/MODIF
Applicant
Advanced Cardiovascular Systems, Inc.
3200 Lakeside Dr.
P.O. Box 58167
Santa Clara,  CA  95052
Applicant Contact JANE E BEGGS
Correspondent
Advanced Cardiovascular Systems, Inc.
3200 Lakeside Dr.
P.O. Box 58167
Santa Clara,  CA  95052
Correspondent Contact JANE E BEGGS
Regulation Number870.1330
Classification Product Code
DQX  
Date Received10/24/1991
Decision Date 01/08/1992
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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