510(k) K250508
K250508 is an FDA 510(k) premarket notification submitted by Vantive US Healthcare, LLC for the device "AK 98 Dialysis Machine (955607)". The FDA issued a decision of Substantially Equivalent on August 1, 2025. 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
- August 1, 2025
- Date Received
- February 21, 2025
- 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