510(k) K243264
DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) by
Sorin Group Italia S.R.L.
— Product Code KDI
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 2025
- Date Received
- October 15, 2024
- 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