Medical Device Manufacturer · US , Englewood , CO

Medtronic Hemotec, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 1992

Recent clearances: PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Medtronic Hemotec, Inc. Hematology ✕

5 devices

1-5 of 5

Cleared Jun 20, 1996

PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS

Hematology · 287d

Cleared Mar 24, 1995

HEPARIN ASSAY CARTRIDGES AND CONTROLS

Hematology · 213d

Cleared Sep 20, 1994

MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER

Hematology · 232d

Cleared Sep 21, 1992

CLOTTRAC COAGULATION CONTROL

Hematology · 63d

Cleared Jul 21, 1992

HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL

Hematology · 81d