510(k) K801193

CLIRANS TE15 HOLLOW FIBER DIALYZER by Terumo America, Inc. — Product Code KDJ

K801193 is an FDA 510(k) premarket notification submitted by Terumo America, Inc. for the device "CLIRANS TE15 HOLLOW FIBER DIALYZER". The FDA issued a decision of Substantially Equivalent on August 12, 1980. The device falls under product code KDJ (Set, Administration, For Peritoneal Dialysis, Disposable), a Class II device regulated under 21 CFR 876.5630. Terumo America, Inc. has at least 10 other 510(k) clearances on record.