Home / 510(k) Clearances / K141019

510(k) K141019

AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED by Fenwal, Inc. — Product Code LKN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2014
Date Received
April 21, 2014
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 Fenwal, Inc.

  • K111702 — AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR A (March 22, 2012)
  • K073339 — BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SI (March 3, 2008)

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)
  • K132429 — SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXC (December 6, 2013)
  • K131744 — SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA O (August 8, 2013)