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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 K053265
Device Name MICRUS GUIDE WIRE, WATUSI 0.014
Applicant
Micrus Endovascular Corporation
610 Palomar Ave.
Sunnyvale,  CA  94085
Applicant Contact MARGARET WEBBER
Correspondent
Micrus Endovascular Corporation
610 Palomar Ave.
Sunnyvale,  CA  94085
Correspondent Contact MARGARET WEBBER
Regulation Number870.1330
Classification Product Code
DQX  
Date Received11/22/2005
Decision Date 04/28/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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