510(k) K963307

GDC PATIENT RETURN ELECTTRODE MODEL 45021 by Target Therapeutics — Product Code HCG

K963307 is an FDA 510(k) premarket notification submitted by Target Therapeutics for the device "GDC PATIENT RETURN ELECTTRODE MODEL 45021". The FDA issued a decision of Substantially Equivalent on December 17, 1996. 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.