510(k) K033372

SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS by Micro Therapeutics, Inc. — Product Code HCG

K033372 is an FDA 510(k) premarket notification submitted by Micro Therapeutics, Inc. for the device "SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS". The FDA issued a decision of Substantially Equivalent on January 9, 2004. The device falls under product code HCG (Device, Neurovascular Embolization), a Class II device regulated under 21 CFR 882.5950. Micro Therapeutics, Inc. has at least 10 other 510(k) clearances on record.