510(k) K042070

HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20 by Medtronic Vascular — Product Code JOX

K042070 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20". The FDA issued a decision of Substantially Equivalent on October 1, 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.