B. Braun Avitum AG
MELSUNGEN Hesse, DE
B. Braun Avitum AG appears in FDA device records in MELSUNGEN Hesse, DE. FDA records list 5 510(k) clearances between and , 21 PMA records and 3 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for B. Braun Avitum AG between 2010 and 2017. The busiest year on record is 2010, with 2. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 2 |
| 2011 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K170574 | Diacap Pro Dialyzer | KDI | Substantially Equivalent | |
| K143482 | xevonta dialyzer | KDI | Substantially Equivalent | |
| K102194 | SOLCART B | KPO | Substantially Equivalent | |
| K100334 | DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811 | KDI | Substantially Equivalent | |
| K083460 | DIALOG WITH ADIMEA OPTION | KDI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007007791 | 3007007791 | B. BRAUN AVITUM AG | Schwarzenberger Weg 73-79, MELSUNGEN Hesse D-34212 DE | 2026 | |
| 3002879653 | 3002879653 | B. Braun Avitum AG | Am Buschberg 1, MELSUNGEN Hesse D-34212 DE | 2026 | |
| 3004176176 | 3004176176 | B. Braun Avitum AG | KATTENVENNER STR. 32, GLANDORF Lower Saxony DE-49219 DE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)
- KDIDialyzer, High Permeability With Or Without Sealed Dialysate System
- LRJDisinfectant, Medical Devices
- MMYLipoprotein, Low Density, Removal
- OUGMedical Device Data System
- FRNPump, Infusion
- LZHPump, Infusion, Enteral
- MEAPump, Infusion, Pca
- FIPSubsystem, Water Purification
- FKQSystem, Dialysate Delivery, Central Multiple Patient
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain