510(k) K141206

EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM by Edwards Lifesciences, LLC — Product Code GAW

K141206 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM". The FDA issued a decision of Substantially Equivalent on January 16, 2015. The device falls under product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), a Class II device regulated under 21 CFR 878.5010. Edwards Lifesciences, LLC has at least 10 other 510(k) clearances on record.