510(k) K963098

PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100) by Deknatel, Inc. — Product Code CAC

K963098 is an FDA 510(k) premarket notification submitted by Deknatel, Inc. for the device "PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100)". The FDA issued a decision of Substantially Equivalent on November 8, 1996. 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.