Home / 510(k) Clearances / K080807

510(k) K080807

BLOOD TUBING SETS (STERILE FLUID PATH) by Nxstage Medical, Inc. — Product Code FJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2008
Date Received
March 21, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Device Class
Class II
Regulation Number
876.5820
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 FJK

  • K251341 — VITAL Tubing Sets for Hemodialysis (January 16, 2026)
  • K251442 — TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) (October 2, 2025)
  • K243607 — Moda-flx Hemodialysis System™ Cartridge (102121-001 ) (December 20, 2024)
  • K213992 — CombiSet Hemodialysis Blood Tubing Set (May 31, 2023)
  • K210782 — Tablo Cartridge (November 26, 2021)
  • K202796 — SANSIN Tubing Sets for Hemodialysis (September 6, 2021)
  • K201866 — NovaLine Tubing Sets for Hemodialysis (March 10, 2021)
  • K171952 — Dimesol Tubing Sets for Hemodialysis (March 30, 2018)
  • K161582 — DORA Tubing Sets for Hemodialysis (June 16, 2017)
  • K150304 — Oxyless Blood Tubing Set (February 24, 2016)