510(k) K151368

Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter by Terumo Bct — Product Code LKN

K151368 is an FDA 510(k) premarket notification submitted by Terumo Bct for the device "Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter". The FDA issued a decision of Substantially Equivalent on September 11, 2015. The device falls under product code LKN (Separator, Automated, Blood Cell And Plasma, Therapeutic), a Class U device.