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510(k) K181049

Spectra Optia Apheresis System by Terumobct, Inc. — Product Code LKN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2018
Date Received
April 20, 2018
Clearance Type
Special
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 Terumobct, Inc.

  • K183081 — Spectra Optia Apheresis System (February 5, 2019)
  • K172590 — Spectra Optia Apheresis System (March 2, 2018)
  • K162365 — T-Cuff (February 16, 2017)
  • K153601 — Spectra Optia Apheresis System (January 14, 2016)
  • 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)

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)
  • 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)
  • K131744 — SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA O (August 8, 2013)