510(k) K151758

ALAR Nasal Valve Stent by Medtronic Xomed, Inc. — Product Code GAT

K151758 is an FDA 510(k) premarket notification submitted by Medtronic Xomed, Inc. for the device "ALAR Nasal Valve Stent". The FDA issued a decision of Substantially Equivalent on October 29, 2015. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Medtronic Xomed, Inc. has at least 10 other 510(k) clearances on record.