Novate Medical, Ltd.
IrelandFDA applicant, unverified
- Devices
- 4
What Novate Medical, Ltd. makes
Novate Medical, Ltd. manufactures the Sentry IVC Filter, a device designed to prevent pulmonary embolism by capturing venous thrombi in the inferior vena cava.
The Sentry IVC Filter is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
- Registry: GUDID
Sentry IVC filter Ref K162875
Regimes: 510(k) Registry: 510(k)Sentry IVC Filter Ref K181202
Regimes: 510(k) Registry: 510(k)Sentry IVC Filter Ref K173236
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Novate Medical, Ltd. have in the registry?
The registry currently lists 4 devices for Novate Medical, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Novate Medical, Ltd.'s devices?
Among its 4 most recently registered devices, Novate Medical, Ltd. has devices listed in FDA 510(k) (3 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Novate Medical, Ltd.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Novate Medical, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Novate Medical, Ltd. in the registry?
The most recently registered devices listed for Novate Medical, Ltd. include Sentry IVC Filter 146155-01 and Sentry IVC filter.