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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Vascular, For Promoting Embolization
510(k) Number K081465
Device Name AXIUM DETACHABLE COIL SYSTEM
Applicant
MICRO THERAPEUTICS, INC.
9775 TOLEDO WAY
IRVINE,  CA  92618
Applicant Contact NEELU MEDHEKAR
Correspondent
MICRO THERAPEUTICS, INC.
9775 TOLEDO WAY
IRVINE,  CA  92618
Correspondent Contact NEELU MEDHEKAR
Regulation Number870.3300
Classification Product Code
KRD  
Date Received05/27/2008
Decision Date 08/19/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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