510(k) K123560

VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM by Codman & Shurtleff, Inc. — Product Code HCG

K123560 is an FDA 510(k) premarket notification submitted by Codman & Shurtleff, Inc. for the device "VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM". The FDA issued a decision of Substantially Equivalent on January 25, 2013. The device falls under product code HCG (Device, Neurovascular Embolization), a Class II device regulated under 21 CFR 882.5950. Codman & Shurtleff, Inc. has at least 10 other 510(k) clearances on record.