510(k) K982712

RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250 by Genzyme Surgical Product (Genzyme Biosurgery) — Product Code CAC

K982712 is an FDA 510(k) premarket notification submitted by Genzyme Surgical Product (Genzyme Biosurgery) for the device "RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250". The FDA issued a decision of Substantially Equivalent on December 18, 1998. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Genzyme Surgical Product (Genzyme Biosurgery) has at least 8 other 510(k) clearances on record.