Cobe Centrysystem 3 Dialysis Control Unit/Cobe Cartridge Blood Tubing Set

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K970253 ↗

FDA Product Code

KDI

Device Class

Class II

Regulation

21 CFR Part 876.5860

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Gambro Hemodialysis Water Treatment System

  Class II

  FDA 510(k) K981085 Active Cleared 18 May 1998

• Gambro Polyflux 17R, Capillary Dialyzer/ Filter

  Class II

  FDA 510(k) K994390 Active Cleared 26 Oct 2000

• Cobe Arylane H1, H4, H6 & H9 Hemodialyzers/Filters

  Class II

  FDA 510(k) K982413 Active Cleared 21 Apr 1999

• Prisma Cfm (Continuous Fluid Management System)

  Class II

  FDA 510(k) K981681 Active Cleared 11 Aug 1998

• Hospal Tipstop

  Class I

  FDA 510(k) K982818 Active Cleared 21 Oct 1998

• Cobe Centrysystem 700 Hg Hemodialyzer

  Class II

  FDA 510(k) K962427 Active Cleared 20 Sep 1996

See all devices from Gambro Healthcare →