510(k) K982340

EXTRACORPOREAL BLOOD CIRCUIT by Haidylena Medical Egypt — Product Code FJK

K982340 is an FDA 510(k) premarket notification submitted by Haidylena Medical Egypt for the device "EXTRACORPOREAL BLOOD CIRCUIT". The FDA issued a decision of Substantially Equivalent on April 30, 1999. The device falls under product code FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve), a Class II device regulated under 21 CFR 876.5820. Haidylena Medical Egypt has at least 1 other 510(k) clearance on record.