510(k) K801192

CLIRANS TE10 HOLLOW FIBER DIALYZER by Terumo America, Inc. — Product Code FJI

K801192 is an FDA 510(k) premarket notification submitted by Terumo America, Inc. for the device "CLIRANS TE10 HOLLOW FIBER DIALYZER". The FDA issued a decision of Substantially Equivalent on August 12, 1980. The device falls under product code FJI (Dialyzer, Capillary, Hollow Fiber), a Class II device regulated under 21 CFR 876.5820. Terumo America, Inc. has at least 10 other 510(k) clearances on record.