Medtronic Hemotec, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Medtronic Hemotec, Inc. makes
Medtronic Hemotec, Inc. manufactures coagulation monitoring devices, including automated coagulation timers, platelet function test assay cartridges, and heparin assay cartridges with controls. These products are designed for laboratory use to measure blood clotting times, platelet function, and heparin levels, supporting diagnostic and treatment monitoring in clinical settings.
The company’s portfolio consists of Class II medical devices, all of which are authorised via the FDA’s 510(k) clearance process. These devices are listed under the FDA’s regulatory framework and are intended for use in the United States.
Catalogue
Clottrac Coagulation Control Ref K923594
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Heparin Assay Cartridges And Controls Ref K944115
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Medtronic Hemotec, Inc. have in the registry?
The registry currently lists 5 devices for Medtronic Hemotec, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medtronic Hemotec, Inc.'s devices?
Among its 5 most recently registered devices, Medtronic Hemotec, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Medtronic Hemotec, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Medtronic Hemotec, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medtronic Hemotec, Inc. in the registry?
The most recently registered devices listed for Medtronic Hemotec, Inc. include CLOTTRAC COAGULATION CONTROL, MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER, PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS and HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL.