Terumobct, Inc.

Medical device manufacturer in Lakewood, CO.

8510(k) clearances
0PMA approvals
0recalls

Device types

510(k) clearances

510(k)DeviceDecision
K183081Spectra Optia Apheresis SystemLKN · Traditional 02/05/2019SE
K181049Spectra Optia Apheresis SystemLKN · Special 11/01/2018SE
K172590Spectra Optia Apheresis SystemLKN · Traditional 03/02/2018SE
K162365T-CuffKCY · Traditional 02/16/2017SE
K153601Spectra Optia Apheresis SystemLKN · Special 01/14/2016SE
K141938Spectra Optia Apheresis System, Spectra Optia Exchange Set (Disposable Blood Tubing Set)LKN · Traditional 03/23/2015SE
K132429Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia Exchange…LKN · Traditional 12/06/2013SE
K131744Spectra Optia Apheresis System, Spectra Optia Single-Needle Connector, Spectra Optia…LKN · Traditional 08/08/2013SE