510(k) K110980

CENTRIMAG RETURN CANNULA KIT by Levitronix, LLC — Product Code DWF

K110980 is an FDA 510(k) premarket notification submitted by Levitronix, LLC for the device "CENTRIMAG RETURN CANNULA KIT". The FDA issued a decision of Substantially Equivalent on June 20, 2011. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Levitronix, LLC has at least 10 other 510(k) clearances on record.