Perimmune, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Perimmune, Inc. makes
Perimmune, Inc. manufactures APO-TEK LP, a Class II medical device designed for localized drug delivery, and AURA TEK FDP, a Class II device intended for targeted fluid delivery or perfusion applications.
These devices are regulated under the FDA’s 510(k) pathway as Class II products and are listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Apo-Tek LP(A) Ref K970302
Regimes: 510(k) Registry: 510(k)Aura Tek Fdp Ref K970353
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Perimmune, Inc. have in the registry?
The registry currently lists 2 devices for Perimmune, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Perimmune, Inc.'s devices?
Among its 2 most recently registered devices, Perimmune, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Perimmune, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Perimmune, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Perimmune, Inc. in the registry?
The most recently registered devices listed for Perimmune, Inc. include APO-TEK LP(A) and AURA TEK FDP.