510(k) K062079
K062079 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210". The FDA issued a decision of Substantially Equivalent on Oct 19, 2006. 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. Baxter Healthcare Corporation has 60 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 19, 2006
- Date Received
- Jul 21, 2006
- 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)