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Terumobct, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K183081Spectra Optia Apheresis SystemFebruary 5, 2019
K181049Spectra Optia Apheresis SystemNovember 1, 2018
K172590Spectra Optia Apheresis SystemMarch 2, 2018
K162365T-CuffFebruary 16, 2017
K153601Spectra Optia Apheresis SystemJanuary 14, 2016
K141938SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET)March 23, 2015
K132429SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SETDecember 6, 2013
K131744SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWAREAugust 8, 2013