510(k) K032497

SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT by Micro Therapeutics, Inc. — Product Code HCG

K032497 is an FDA 510(k) premarket notification submitted by Micro Therapeutics, Inc. for the device "SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT". The FDA issued a decision of Substantially Equivalent on September 25, 2003. 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.