Clearance Summary
CombiSet Hemodialysis Blood Tubing Set received FDA 510(k) clearance under submission number K213992, 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 2023-05-31.
- Submission: K213992
- 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: 2023-05-31
Classification & Regulation
This clearance is catalogued under FDA product code FJK and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.