xevonta dialyzer
FDA 510(k) clearance K143482 · decided 2016-03-01
Clearance details
- K-number
- K143482
- Device name
- xevonta dialyzer
- Applicant
- B. Braun Avitum AG
- Decision
- Substantially Equivalent
- Date received
- 2014-12-08
- Decision date
- 2016-03-01
- Days to decision
- 449 days
- Clearance type
- Traditional
- Product code
- KDI
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Melsungen, DE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| H.E.L.P. Futura Apheresis System (P940016/S027) | B. Braun Avitum AG | 2019-06-07 |
| Heparin-Induced Extracorporeal LDL Precipitation (H.E.L.P.) Futura Apheresis System (P940016/S026) | B. Braun Avitum AG | 2019-05-22 |
| H.E.L.P. Futura Apheresis System (P940016/S025) | B. Braun Avitum AG | 2018-06-28 |
| Heparin-Induced Extracorporeal LDL Precipitation (H.E.L.P.) Futura Apheresis System (P940016/S024) | B. Braun Avitum AG | 2017-11-07 |
| Heparin_Induced Extracorporeal LDL Precipitation (H.E.L.P.) Futura Apheresis System (P940016/S023) | B. Braun Avitum AG | 2017-07-06 |
| H.E.L.P. Futura Apheresis System (P940016/S022) | B. Braun Avitum AG | 2016-11-15 |
| HEPARIN-INDUCED EXTRACORPOREAL LDL PRECIPITATION (H.E.L.P.) FUTURA APHERESIS SYSTEM (P940016/S021) | B. Braun Avitum AG | 2016-09-09 |
| H.E.L.P. PLASMAT FUTURA SYSTEM (P940016/S020) | B. Braun Avitum AG | 2016-03-17 |