Mallinckrodt Medical Tpi, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Mallinckrodt Medical Tpi, Inc. makes
Mallinckrodt Medical TPI, Inc. manufactures tracheostomy-related devices, including reusable cannula tubes with modified heads, fenestrated inner cannulas, and speaking valves designed for patients requiring tracheostomy care. Their products also include speaking valves with oxygen ports, enabling phonation while allowing oxygen delivery through the tracheostomy.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company operates from the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Ssv Phonate(Tm) Shiley Speaking Valve Ref K945406
Regimes: 510(k) Registry: 510(k)Shiley Fenestrated Reusable Inner Cannula, Modif Ref K930895
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Mallinckrodt Medical Tpi, Inc. have in the registry?
The registry currently lists 4 devices for Mallinckrodt Medical Tpi, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mallinckrodt Medical Tpi, Inc.'s devices?
Among its 4 most recently registered devices, Mallinckrodt Medical Tpi, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Mallinckrodt Medical Tpi, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Mallinckrodt Medical Tpi, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mallinckrodt Medical Tpi, Inc. in the registry?
The most recently registered devices listed for Mallinckrodt Medical Tpi, Inc. include SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT, REUSABLE CANNULA TRACHEOSTOMY TUBES, MODIFIED HEADS, SSV PHONATE(TM) SHILEY SPEAKING VALVE and SHILEY FENESTRATED REUSABLE INNER CANNULA, MODIF.