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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular Occluding, Temporary
510(k) Number K080861
Device Name MICRUS ASCENT OCCLUSION BALLOON CATHETER
Applicant
MICRUS ENDOVASCULAR CORPORATION
821 FOX LANE
SAN JOSE,  CA  95131
Applicant Contact PATRICK LEE
Correspondent
MICRUS ENDOVASCULAR CORPORATION
821 FOX LANE
SAN JOSE,  CA  95131
Correspondent Contact PATRICK LEE
Regulation Number870.4450
Classification Product Code
MJN  
Date Received03/27/2008
Decision Date 08/27/2008
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
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