Home / 510(k) Clearances / K961706

510(k) K961706

P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR by Fresenius USA, Inc. — Product Code LKN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1996
Date Received
May 2, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Separator, Automated, Blood Cell And Plasma, Therapeutic
Device Class
Class U
Regulation Number
Review Panel
GU
Submission Type

Other clearances by Fresenius USA, Inc.

  • K992275 — FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VO (August 4, 1999)
  • K970700 — FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX (September 15, 1998)
  • K974584 — FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F80 (May 14, 1998)
  • K973378 — C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SE (November 3, 1997)
  • K961465 — 2008H ON LINE CLEARANCE MONITOR (July 3, 1997)
  • K955762 — PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM (July 31, 1996)
  • K941460 — FRESENIUS BLOOD TEMPERATURE MONITOR (July 3, 1996)
  • K955423 — PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM (June 13, 1996)
  • K930181 — BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE (November 29, 1995)
  • K944767 — DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER (November 29, 1995)

Other clearances for product code LKN

  • K192150 — AMICUS Separator System (November 13, 2019)
  • K183081 — Spectra Optia Apheresis System (February 5, 2019)
  • K180615 — AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, (December 4, 2018)
  • K181049 — Spectra Optia Apheresis System (November 1, 2018)
  • K172590 — Spectra Optia Apheresis System (March 2, 2018)
  • K153601 — Spectra Optia Apheresis System (January 14, 2016)
  • K151368 — Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), (September 11, 2015)
  • K141938 — SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUB (March 23, 2015)
  • K141019 — AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED (June 10, 2014)
  • K132429 — SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXC (December 6, 2013)