510(k) K091921

CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP by Codman & Shurtleff, Inc. — Product Code HCH

K091921 is an FDA 510(k) premarket notification submitted by Codman & Shurtleff, Inc. for the device "CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP". The FDA issued a decision of Substantially Equivalent on September 8, 2009. The device falls under product code HCH (Clip, Aneurysm), a Class II device regulated under 21 CFR 882.5200. Codman & Shurtleff, Inc. has at least 10 other 510(k) clearances on record.