510(k) K001734

FOGARTY VALVULOTOME, MODEL 700091 by Edwards Lifesciences, LLC — Product Code MGZ

K001734 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "FOGARTY VALVULOTOME, MODEL 700091". The FDA issued a decision of Substantially Equivalent on March 26, 2001. The device falls under product code MGZ (Valvulotome), a Class II device regulated under 21 CFR 870.4885. Edwards Lifesciences, LLC has at least 10 other 510(k) clearances on record.