510(k) K031554

S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM by Genzyme Biosurgery — Product Code CAC

K031554 is an FDA 510(k) premarket notification submitted by Genzyme Biosurgery for the device "S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on July 25, 2003. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Genzyme Biosurgery has at least 3 other 510(k) clearances on record.