K141752 is an FDA 510(k) clearance for the NXSTAGE SYSTEM ONE. This device is classified as a Ultrafiltration-controlled Nocturnal Dialysate Delivery System (Class II - Special Controls, product code ODN).
Submitted by Nxstage Medical, Inc. (Lawrence, US). The FDA issued a Cleared decision on December 19, 2014, 172 days after receiving the submission on June 30, 2014.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5860. 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..
| 510(k) Number | K141752 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 2014 |
| Decision Date | December 19, 2014 |
| Days to Decision | 172 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | ODN — Ultrafiltration-controlled Nocturnal Dialysate Delivery System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5860 |
| 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. |