ODN · Class II · 21 CFR 876.5860

FDA Product Code ODN: Ultrafiltration-controlled Nocturnal Dialysate Delivery System

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.

Leading manufacturers include Nxstage Medical, Inc..

2
Total
2
Cleared
137d
Avg days
2014
Since

FDA 510(k) Cleared Ultrafiltration-controlled Nocturnal Dialysate Delivery System Devices (Product Code ODN)

2 devices
1–2 of 2
Cleared Jun 04, 2015
NxStage System One
K150472
Nxstage Medical, Inc.
Gastroenterology & Urology · 101d
Cleared Dec 19, 2014
NXSTAGE SYSTEM ONE
K141752
Nxstage Medical, Inc.
Gastroenterology & Urology · 172d

About Product Code ODN - Regulatory Context