510(k) Report

Devices descending from K961000

4 later devices reach Capiox SX18 Hollow Fiber Oxygenator with and Without Detachable Hardshell… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130359Capiox SX18 Hollow Fiber Oxygenator with Detachable Hardshell Reservoir, Capiox SX25…Terumo Cardiovascular Systems Corp.20132—
+1K970463Capiox E Hollow Fiber Oxygenator with Integrated Heat Exchanger/Arterial ReservoirTerumo Medical Corp.19970—
+2K153143Capiox Advance Hardshell ReservoirTerumo Cardiovascular Systems Corporation20150—
+2K153140Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/…Terumo Cardiovascular Systems Corp.20150—