Clearance Summary
APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS) received FDA 510(k) clearance under submission number K001250, sponsored by Asahi Medical 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 2000-08-16.
- Submission: K001250
- Applicant / Sponsor: Asahi Medical Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5860
- Decision date: 2000-08-16
Classification & Regulation
This clearance is catalogued under FDA product code KDI and 21 CFR 876.5860, within the Gastroenterology, Urology review panel as a Class II device.