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510(k) K801559

HOLLO FIBER DIALYZER by Renal Devices, Inc. — Product Code FJI

K801559 is an FDA 510(k) premarket notification submitted by Renal Devices, Inc. for the device "HOLLO FIBER DIALYZER". The FDA issued a decision of Substantially Equivalent on October 31, 1980. The device falls under product code FJI (Dialyzer, Capillary, Hollow Fiber), a Class II device regulated under 21 CFR 876.5820. Renal Devices, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1980
Date Received
July 8, 1980
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 Renal Devices, Inc.

  • K810612 — HEMOPHRON (April 29, 1981)
  • K802075 — HOLLOW FIBER DIALYZER HOLDER (September 16, 1980)
  • K790696 — RDI-1 HOLLOW FIBER DIALYZER (June 20, 1979)

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