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510(k) K141752

NXSTAGE SYSTEM ONE by Nxstage Medical, Inc. — Product Code ODN

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.

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  • K170469 — NxStage System One Plus (May 9, 2017)
  • K150472 — NxStage System One (June 4, 2015)
  • K143313 — NxStage Therapeutic Plasma Exchange (TPE) Cartridge (March 20, 2015)
  • K134019 — MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECT (September 11, 2014)

Other clearances for product code ODN

  • K150472 — NxStage System One (June 4, 2015)