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510(k) K030470

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 2003
Date Received
February 12, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Dialysate Delivery, Sealed
Device Class
Class II
Regulation Number
876.5860
Review Panel
GU
Submission Type

Other clearances by Nxstage Medical, Inc.

  • K232803 — NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) (March 14, 2024)
  • K233213 — NxStage PureFlow Solution (January 18, 2024)
  • 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)
  • K150472 — NxStage System One (June 4, 2015)
  • K143313 — NxStage Therapeutic Plasma Exchange (TPE) Cartridge (March 20, 2015)
  • K141752 — NXSTAGE SYSTEM ONE (December 19, 2014)

Other clearances for product code FII

  • K881270 — GAMBRO MULTIPURPOSE SYSTEM MPS-10 (August 24, 1988)
  • K872364 — HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 (October 13, 1987)
  • K862716 — HEMOFILTRATION SYSTEM 10 (September 9, 1986)
  • K822386 — COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA (October 6, 1982)