Medtronic Vascular - FDA 510(k) Cleared Devices
Recent clearances: Steerant™ Super Stiff Guidewire, 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter, 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter
475
Total
453
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medtronic Vascular Hematology ✕
6 devices
Cleared
Dec 03, 2004
HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
Hematology
25d
Cleared
Oct 18, 2004
HEPARINASE HR ACT CONTROL, MODEL 550-12
Hematology
68d
Cleared
Oct 18, 2004
PURPLE/BLACK HEPARIN ASSAY CONTROL
Hematology
63d
Cleared
Oct 01, 2004
HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20
Hematology
60d
Cleared
Aug 12, 2002
MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET...
Hematology
63d
Cleared
Oct 31, 1995
ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS
Hematology
75d