510(k) K143482
K143482 is an FDA 510(k) premarket notification submitted by B. Braun Avitum AG for the device "xevonta dialyzer". The FDA issued a decision of Substantially Equivalent on Mar 1, 2016. The device falls under product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System), a Class II device regulated under 21 CFR 876.5860. B. Braun Avitum AG has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 1, 2016
- Date Received
- Dec 8, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Device Class
- Class II
- Regulation Number
- 876.5860
- Review Panel
- GU
- Submission Type
- 510(k)