Clearance Summary
Acute Dual Lumen Hemodialysis Catheter received FDA 510(k) clearance under submission number K200426, sponsored by Health Line International Corporation. 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 2020-12-24.
- Submission: K200426
- Applicant / Sponsor: Health Line International Corporation
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5540
- Decision date: 2020-12-24
Classification & Regulation
This clearance is catalogued under FDA product code MPB and 21 CFR 876.5540, within the Gastroenterology, Urology review panel as a Class II device.