Apogee, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Apogee, Inc. makes
Apogee, Inc. manufactures coiled extension tubing for low-pressure injection systems and urological catheters designed for medical procedures.
These products are classified as Class II devices under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Urological Catheter Ref K992137
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Apogee, Inc. have in the registry?
The registry currently lists 2 devices for Apogee, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Apogee, Inc.'s devices?
Among its 2 most recently registered devices, Apogee, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Apogee, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Apogee, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Apogee, Inc. in the registry?
The most recently registered devices listed for Apogee, Inc. include LOW PRESSURE INJECTION TUBING, COILED LINE, EXTENSION TUBING and UROLOGICAL CATHETER.