The following data is part of a premarket notification filed by B. Braun Avitum Ag with the FDA for Xevonta Dialyzer.
| Device ID | K143482 |
| 510k Number | K143482 |
| Device Name: | Xevonta Dialyzer |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | B. Braun Avitum AG Am Buschberg 1 Melsungen, DE D-34212 |
| Contact | Giuliana Gavioli |
| Correspondent | Tracy Maddock B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-08 |
| Decision Date | 2016-03-01 |
| Summary: | summary |