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510(k) K945746

GAMBRO LUNDIA 94-500 DIALYZER by Cobe Renal Care, Inc. — Product Code FJI

K945746 is an FDA 510(k) premarket notification submitted by Cobe Renal Care, Inc. for the device "GAMBRO LUNDIA 94-500 DIALYZER". The FDA issued a decision of Substantially Equivalent on September 8, 1995. The device falls under product code FJI (Dialyzer, Capillary, Hollow Fiber), a Class II device regulated under 21 CFR 876.5820. Cobe Renal Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1995
Date Received
November 23, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, Capillary, Hollow Fiber
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Cobe Renal Care, Inc.

  • K955497 — GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET (September 25, 1997)
  • K955592 — COBE CENTRYSYSTEM 14 PES HEMODIALYZERS (April 30, 1997)
  • K955487 — GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS (April 18, 1997)
  • K946279 — PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) (February 10, 1997)
  • K954003 — COBE HEMODYNAMIC RECIRCULATION MONITOR (February 6, 1997)
  • K960474 — COBE CENTRYSYSTEM 600 HG HEMODIALYZERS (August 14, 1996)
  • K944436 — COBE CENTRYSYSTEM CS 200 DIALYZER (January 29, 1996)
  • K951311 — GAMBRO HC 14R HEMOCONCENTRATOR (January 11, 1996)
  • K952342 — GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODIALYZERS (September 15, 1995)
  • K945747 — GAMBRO LUNDIA 94-600 DIALYZER (September 8, 1995)

Other clearances for product code FJI

  • K190459 — Hemoflow F3 and F4 Dialyzers (August 23, 2019)
  • K122952 — NIPRO PUREFLUX-L HEMODIALYZER (December 4, 2013)
  • K043342 — POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS (May 27, 2005)
  • K010366 — DISPOSABLE STORAGE CAP (November 28, 2001)
  • K011148 — ULTRACONCENTRATOR SYSTEM (June 13, 2001)
  • K002761 — FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS (December 4, 2000)
  • K991908 — IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS (April 17, 2000)
  • K992594 — A-15 HEMODIALYZER (September 24, 1999)
  • K992565 — A-18 HEMODIALYZER (September 23, 1999)
  • K991512 — ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X (July 29, 1999)

FDA data resources