510(k) K944232

AUTOFLO INTRA-OP SHED BLOOD AUTORTRANSFUSTION SYS by Haemonetics Corp. — Product Code CAC

K944232 is an FDA 510(k) premarket notification submitted by Haemonetics Corp. for the device "AUTOFLO INTRA-OP SHED BLOOD AUTORTRANSFUSTION SYS". The FDA issued a decision of Substantially Equivalent on July 20, 1995. 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.