510(k) K861677

PHARMASEAL MEDI-VAC INTRA-OPER. AUTOTRANSFUS. KIT by American Pharmaseal Div. Ahsc — Product Code CAC

K861677 is an FDA 510(k) premarket notification submitted by American Pharmaseal Div. Ahsc for the device "PHARMASEAL MEDI-VAC INTRA-OPER. AUTOTRANSFUS. KIT". The FDA issued a decision of Substantially Equivalent on June 16, 1986. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. American Pharmaseal Div. Ahsc has at least 10 other 510(k) clearances on record.