Clearance Summary
DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS received FDA 510(k) clearance under submission number K102833, sponsored by Foshan Nanhai Bai HE Medical Technology Co., Ltd.. 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 2011-11-18.
- Submission: K102833
- Applicant / Sponsor: Foshan Nanhai Bai HE Medical Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5540
- Decision date: 2011-11-18
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.