Clearance Summary
CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line received FDA 510(k) clearance under submission number K201207, 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 2020-09-18.
- Submission: K201207
- 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: 2020-09-18
Classification & Regulation
This clearance is catalogued under FDA product code KOC and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.