510(k) K040415

PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT by Synovis Surgical Innovations — Product Code DXZ

K040415 is an FDA 510(k) premarket notification submitted by Synovis Surgical Innovations for the device "PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT". The FDA issued a decision of Substantially Equivalent on April 14, 2004. The device falls under product code DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene), a Class II device regulated under 21 CFR 870.3470. Synovis Surgical Innovations has at least 7 other 510(k) clearances on record.