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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 K091641
FOIA Releasable 510(k) K091641
Device Name HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT)
Applicant
MICROVENTION, INC.
75 COLUMBIA
SUITE A
ALISO VIEJO,  CA  92656 -1408
Applicant Contact Naomi Gong
Correspondent
MICROVENTION, INC.
75 COLUMBIA
SUITE A
ALISO VIEJO,  CA  92656 -1408
Correspondent Contact Naomi Gong
Regulation Number882.5950
Classification Product Code
HCG  
Date Received06/04/2009
Decision Date 06/30/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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