510(k) K140197

PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM by Teleflexmedical, Inc. — Product Code CAC

K140197 is an FDA 510(k) premarket notification submitted by Teleflexmedical, Inc. for the device "PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on October 21, 2014. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Teleflexmedical, Inc. has at least 10 other 510(k) clearances on record.