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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 K090274
Device Name MICRUS ONE 2 ONE GUIDEWIRE AND SOFT GUIDEWIRE
Applicant
Micrus Endovascular Corporation
821 Fox Ln.
San Jose,  CA  95131
Applicant Contact PATRICK LEE
Correspondent
Micrus Endovascular Corporation
821 Fox Ln.
San Jose,  CA  95131
Correspondent Contact PATRICK LEE
Regulation Number870.1330
Classification Product Code
DQX  
Date Received02/04/2009
Decision Date 03/03/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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