Clearance Summary
pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 received FDA 510(k) clearance under submission number K233159, sponsored by Fresenius Medical Care Renal Therapies Group, LLC. 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 2023-12-01.
- Submission: K233159
- Applicant / Sponsor: Fresenius Medical Care Renal Therapies Group, LLC
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 2023-12-01
Classification & Regulation
This clearance is catalogued under FDA product code KPO and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.