Clearance Summary
AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory received FDA 510(k) clearance under submission number K201809, sponsored by Baxter Healthcare Corportation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2021-03-10.
- Submission: K201809
- Applicant / Sponsor: Baxter Healthcare Corportation
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5860
- Decision date: 2021-03-10
Classification & Regulation
This clearance is catalogued under FDA product code KDI and 21 CFR 876.5860, within the Gastroenterology, Urology review panel as a Class II device.