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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 K033372
Device Name SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS
Applicant
MICRO THERAPEUTICS, INC.
2 GOODYEAR
IRVINE,  CA  92618
Applicant Contact FLORIN TRUUVERT
Correspondent
MICRO THERAPEUTICS, INC.
2 GOODYEAR
IRVINE,  CA  92618
Correspondent Contact FLORIN TRUUVERT
Regulation Number882.5950
Classification Product Code
HCG  
Date Received10/22/2003
Decision Date 01/09/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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