510(k) Report

Devices descending from K141938

2 later devices reach Spectra Optia Apheresis System, Spectra Optia Exchange Set (Disposable Blood… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151368Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra…Terumo Bct20151—
+2K153601Spectra Optia Apheresis SystemTerumobct, Inc.20160—