510(k) K043080

HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR by Medtronic Vascular — Product Code JOX

K043080 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR". The FDA issued a decision of Substantially Equivalent on December 3, 2004. The device falls under product code JOX (Analyzer, Heparin, Automated), a Class II device regulated under 21 CFR 864.5680. Medtronic Vascular has at least 10 other 510(k) clearances on record.