Estracorporeal, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 2
What Estracorporeal, Inc. makes
Estracorporeal, Inc. manufactures coil dialysis systems, including the DM-360 and DM-360- models, designed for extracorporeal blood purification. The company also produces a membrane-based autotransfusion system for recovering and reinfusing blood during surgical procedures.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company is based in the United States.
Catalogue
Coil Dialysis, Models Dm-360 And Dm-360- Ref K790382
510(k) 510(k)Mat Membrane Autotransfusion System Ref K915130
510(k) 510(k)
Frequently asked questions
How many devices does Estracorporeal, Inc. have in the registry?
The registry currently lists 2 devices for Estracorporeal, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Estracorporeal, Inc.'s devices?
Among its 2 most recently registered devices, Estracorporeal, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Estracorporeal, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Estracorporeal, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Estracorporeal, Inc. in the registry?
The most recently registered devices listed for Estracorporeal, Inc. include COIL DIALYSIS, MODELS DM-360 AND DM-360- and MAT MEMBRANE AUTOTRANSFUSION SYSTEM.