FDA 510(k) Applications for Medical Device Product Code "JOX"
(Analyzer, Heparin, Automated)

FDA 510(k) Number Applicant Device Name Decision Date
K993519 CARDIOVASCULAR DIAGNOSTICS, INC. RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST 01/14/2000
K101271 MEDTRONIC INC. HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX 10/13/2010
K111339 MEDTRONIC INC. HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) 06/08/2011
K102953 MEDTRONIC INC. HEPARIN DOSE RESPONSE CARTRIDGE 11/04/2010
K051040 MEDTRONIC PERFUSION SYSTEMS HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR 05/24/2005
K042070 MEDTRONIC VASCULAR HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20 10/01/2004
K043080 MEDTRONIC VASCULAR HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR 12/03/2004


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