510(k) K993581

HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOLITE 2 FAMILY OF AUTOLOGOUS BLOOD RECOVER by Haemonetics Corp. — Product Code CAC

K993581 is an FDA 510(k) premarket notification submitted by Haemonetics Corp. for the device "HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOLITE 2 FAMILY OF AUTOLOGOUS BLOOD RECOVER". The FDA issued a decision of Substantially Equivalent on November 18, 1999. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Haemonetics Corp. has at least 10 other 510(k) clearances on record.