510(k) K141752
K141752 is an FDA 510(k) premarket notification submitted by Nxstage Medical, Inc. for the device "NXSTAGE SYSTEM ONE". The FDA issued a decision of Substantially Equivalent on December 19, 2014. The device falls under product code ODN (Ultrafiltration-Controlled Nocturnal Dialysate Delivery System), a Class II device regulated under 21 CFR 876.5860. Nxstage Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2014
- Date Received
- June 30, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ultrafiltration-Controlled Nocturnal Dialysate Delivery System
- Device Class
- Class II
- Regulation Number
- 876.5860
- Review Panel
- GU
- Submission Type
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.