Probe-Tek, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Probe-Tek, Inc. makes
Probe-Tek, Inc. manufactures medical devices designed for blood management, including a heparin adsorbent for removing excess heparin from blood and a pro-coagulant agent called Pro-Clot to promote clotting in specific clinical applications.
The company’s portfolio consists of Class II devices, which are regulated under the FDA’s 510(k) clearance process in the United States. These products are listed in the FDA’s 510(k) database, adhering to U.S. medical device regulations.
Catalogue
Pt Heparin Adsorbent Ref K870771
Regimes: 510(k) Registry: 510(k)Pt Pro-Clot Ref K874373
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Probe-Tek, Inc. have in the registry?
The registry currently lists 2 devices for Probe-Tek, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Probe-Tek, Inc.'s devices?
Among its 2 most recently registered devices, Probe-Tek, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Probe-Tek, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Probe-Tek, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Probe-Tek, Inc. in the registry?
The most recently registered devices listed for Probe-Tek, Inc. include PT HEPARIN ADSORBENT and PT PRO-CLOT.