Clearance Summary
Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit received FDA 510(k) clearance under submission number K213602, sponsored by Covidien, 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 2022-01-14.
- Submission: K213602
- Applicant / Sponsor: Covidien, LLC
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5630
- Decision date: 2022-01-14
Classification & Regulation
This clearance is catalogued under FDA product code FJS and 21 CFR 876.5630, within the Gastroenterology, Urology review panel as a Class II device.