510(k) Report

Devices descending from K130520

6 later devices reach Capiox FX15 and FX25 Hollow Fiber Oxygenator/Reservoir through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140774Terumo Capiox FX15 and FX25 Hollow Fiber Oxygenator/ReservoirTerumo Cardiovascular Systems Corporation20145—
+2K151791Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir…Terumo Cardiovascular Systems Corporation201522
+2K151389Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell…Terumo Cardiovascular Systems Corporation20151—
+3K242503Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)Eurosets S.R.L20250—
+3K180950Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19…Terumo Cardiovascular Systems Corporation201805
+3K172071Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19…Terumo Cardiovascular Systems Corporation20180—