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510(k) K150472

NxStage System One by Nxstage Medical, Inc. — Product Code ODN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2015
Date Received
February 23, 2015
Clearance Type
Special
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.

Other clearances by Nxstage Medical, Inc.

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  • K230632 — VersiHD with GuideMe software (August 11, 2023)
  • K183158 — NxStage Cartridge Express with Speedswap (August 9, 2019)
  • K181991 — NxStage Connected Health System (September 26, 2018)
  • K171331 — NxStage System One (August 24, 2017)
  • K170469 — NxStage System One Plus (May 9, 2017)
  • K143313 — NxStage Therapeutic Plasma Exchange (TPE) Cartridge (March 20, 2015)
  • K141752 — NXSTAGE SYSTEM ONE (December 19, 2014)
  • K134019 — MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECT (September 11, 2014)

Other clearances for product code ODN

  • K141752 — NXSTAGE SYSTEM ONE (December 19, 2014)