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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Neurovascular Embolization
510(k) Number K070707
Device Name MICRUS MICROCOIL SYSTEM
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 Number882.5950
Classification Product Code
HCG  
Date Received03/14/2007
Decision Date 04/06/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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