Clearance Summary
FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS received FDA 510(k) clearance under submission number K012242, sponsored by Fresenius Medical Care North America. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2001-08-16.
- Submission: K012242
- Applicant / Sponsor: Fresenius Medical Care North America
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 2001-08-16
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.