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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 K852123
Device Name WHOLEY HI-TORQUE GUIDE WIRES
Applicant
Advanced Cardiovascular Systems, Inc.
1395 Charleston Rd.
Mountain View,  CA  94043
Applicant Contact JANE E BEGGS
Correspondent
Advanced Cardiovascular Systems, Inc.
1395 Charleston Rd.
Mountain View,  CA  94043
Correspondent Contact JANE E BEGGS
Regulation Number870.1330
Classification Product Code
DQX  
Date Received05/15/1985
Decision Date 06/19/1985
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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