510(k) K232171
K232171 is an FDA 510(k) premarket notification submitted by Tecnoideal America for the device "Purema® H Hemoconcentrator (EtO Sterilized)". The FDA issued a decision of Substantially Equivalent on February 7, 2024. 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.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 7, 2024
- Date Received
- July 21, 2023
- 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