510(k) Report

Devices descending from K130359

2 later devices reach Capiox SX18 Hollow Fiber Oxygenator with Detachable Hardshell Reservoir… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153143Capiox Advance Hardshell ReservoirTerumo Cardiovascular Systems Corporation20150—
+1K153140Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/…Terumo Cardiovascular Systems Corp.20150—