Data / Medical devices / Germany / B. Braun Avitum Saxonia GmbH
B. Braun Avitum Saxonia GmbH: FDA-registered device maker in RADEBERG Saxony, Germany, 3 510(k) clearances
B. Braun Avitum Saxonia GmbH is registered with the FDA (registration 3004201412) in RADEBERG Saxony, Germany. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 11, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004201412
- Address
- Juri-Gagarin-Strasse, 13, RADEBERG Saxony, Germany, D-01454
- Owner or operator
- B. BRAUN Avitum AG (9057188)
- Roles
- Manufacturer
- First device listed
- November 16, 2006
- Registered through
- 2026
- Brand names listed
- DIACAP ULTRA, Diacap Pro, xevonta
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | 2 | Manufacturer | accessdata.fda.gov |
| System, Dialysate Delivery, Central Multiple Patient | FKQ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 11, 2017 | K170574 | Diacap Pro Dialyzer | KDI | Substantially Equivalent | B. Braun Avitum AG | accessdata.fda.gov |
| March 1, 2016 | K143482 | xevonta dialyzer | KDI | Substantially Equivalent | B. Braun Avitum AG | accessdata.fda.gov |
| June 9, 2006 | K052764 | DIACAP ULTRA DIALYSIS FLUID FILTER | FKQ | Substantially Equivalent | B. Braun Medizintechnologie GmbH | accessdata.fda.gov |
Compare with other makers
Updated August 11, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.