VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM

About This 510(k) Submission

K123560 is an FDA 510(k) clearance for the VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM, a Device, Neurovascular Embolization (Class II — Special Controls, product code HCG), submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on January 25, 2013, 67 days after receiving the submission on November 19, 2012. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5950.