510(k) K822687

REUSABLE FOGARTY FLEXIBLE CALIBRATOR by American Edwards Laboratories — Product Code DWP

K822687 is an FDA 510(k) premarket notification submitted by American Edwards Laboratories for the device "REUSABLE FOGARTY FLEXIBLE CALIBRATOR". The FDA issued a decision of Substantially Equivalent on October 4, 1982. The device falls under product code DWP (Dilator, Vessel, Surgical), a Class II device regulated under 21 CFR 870.4475. American Edwards Laboratories has at least 10 other 510(k) clearances on record.