510(k) K963850

PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM by Deknatel, Inc. — Product Code CAC

K963850 is an FDA 510(k) premarket notification submitted by Deknatel, Inc. for the device "PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on April 22, 1997. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Deknatel, Inc. has at least 10 other 510(k) clearances on record.