510(k) K051425

NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR by Micro Therapeutics, Inc. — Product Code HCG

K051425 is an FDA 510(k) premarket notification submitted by Micro Therapeutics, Inc. for the device "NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR". The FDA issued a decision of Substantially Equivalent on June 22, 2005. 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.