510(k) K831424

THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101 by Extracorporeal Medical Specialities, Inc. — Product Code FJK

K831424 is an FDA 510(k) premarket notification submitted by Extracorporeal Medical Specialities, Inc. for the device "THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101". The FDA issued a decision of Substantially Equivalent on October 14, 1983. 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. Extracorporeal Medical Specialities, Inc. has at least 10 other 510(k) clearances on record.