Clearance Summary
staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 6 inch, staysafe catheter extension set with Luer-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 18 inch, staysafe to Luer-Lock adapter, 4 inch received FDA 510(k) clearance under submission number K173593, 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 2018-05-21.
- Submission: K173593
- Applicant / Sponsor: Fresenius Medical Care Renal Therapies Group, LLC
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5630
- Decision date: 2018-05-21
Classification & Regulation
This clearance is catalogued under FDA product code KDJ and 21 CFR 876.5630, within the Gastroenterology, Urology review panel as a Class II device.