510(k) Report

Devices descending from K002238

5 later devices reach Capiox SX Hardshell Reservoir with X-Coating through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013526Capiox RX Hardshell ReservoirTerumo Cardiovascular Systems Corp.20014—
+2K130359Capiox SX18 Hollow Fiber Oxygenator with Detachable Hardshell Reservoir, Capiox SX25…Terumo Cardiovascular Systems Corp.20132—
+2K030505Capiox Cardiotomy ReservoirTerumo Cardiovascular Systems Corp.20030—
+3K153143Capiox Advance Hardshell ReservoirTerumo Cardiovascular Systems Corporation20150—
+3K153140Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/…Terumo Cardiovascular Systems Corp.20150—