510(k) Report

Devices descending from K071079

4 later devices reach Spectra Optia Apheresis System, Spectra Optia Exchange Set, Model 61000, 10200 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151368Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra…Terumo Bct20151—
+1K141938Spectra Optia Apheresis System, Spectra Optia Exchange Set (Disposable Blood Tubing Set)Terumobct, Inc.20152—
+1K131744Spectra Optia Apheresis System, Spectra Optia Single-Needle Connector, Spectra Optia…Terumobct, Inc.20130—
+2K153601Spectra Optia Apheresis SystemTerumobct, Inc.20160—