ODN — Ultrafiltration-Controlled Nocturnal Dialysate Delivery System Class II
FDA product code ODN covers "Ultrafiltration-Controlled Nocturnal Dialysate Delivery System", a Class II medical device regulated under 21 CFR 876.5860. Submissions are reviewed by the Gastroenterology, Urology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ODN
- Device Class
- Class II
- Regulation Number
- 876.5860
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
Hemodialysis performed with a high permeability hemodialyzer and an ultrafiltration-controlled system. Nocturnal hemodialysis for patients with end-stage renal disease (chronic dialysis) or acute renal failure (acute dialysis) performed with a high permeability hemodialyzer and an ultrafiltration-controlled system.