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510(k) K952343

FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER by National Medical Care, Medical Products Div., Inc. — Product Code FJI

K952343 is an FDA 510(k) premarket notification submitted by National Medical Care, Medical Products Div., Inc. for the device "FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER". The FDA issued a decision of Substantially Equivalent on December 22, 1995. The device falls under product code FJI (Dialyzer, Capillary, Hollow Fiber), a Class II device regulated under 21 CFR 876.5820. National Medical Care, Medical Products Div., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1995
Date Received
May 19, 1995
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 National Medical Care, Medical Products Div., Inc.

  • K962081 — COMBILINES HEMODIALYSIS BLOOD TUBING SET (November 1, 1996)
  • K941757 — FORMALIN REUSE CART (January 22, 1996)
  • K930843 — RAPID DISCONNECT Y-SET, CAT. NO. 48-7000 (August 31, 1994)
  • K914790 — HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R (March 5, 1993)
  • K920697 — DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP (September 21, 1992)
  • K920029 — DEXTROLYTE II CAPD TRNSFER SET (September 21, 1992)
  • K920693 — DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9 (September 21, 1992)
  • K920586 — DEXTROLYTE II PERITONEAL DIALYSIS ADMIN. SET (September 21, 1992)
  • K920797 — HEMODIALYSIS BLOOD TUBING SET (September 21, 1992)
  • K915628 — DEXTROLYTE II PERITONEAL DIALYSIS PUMP (March 16, 1992)

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