510(k) K951256

DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC) by Target Therapeutics — Product Code HCG

K951256 is an FDA 510(k) premarket notification submitted by Target Therapeutics for the device "DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC)". The FDA issued a decision of Substantially Equivalent on September 8, 1995. The device falls under product code HCG (Device, Neurovascular Embolization), a Class II device regulated under 21 CFR 882.5950. Target Therapeutics has at least 10 other 510(k) clearances on record.