510(k) K151386

C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic by Atrium Medical Corporation — Product Code FTL

K151386 is an FDA 510(k) premarket notification submitted by Atrium Medical Corporation for the device "C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic". The FDA issued a decision of Substantially Equivalent on October 22, 2015. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Atrium Medical Corporation has at least 5 other 510(k) clearances on record.