510(k) Report

Devices descending from K891230

2 later devices reach Maxima* Hollow Fiber Oxygenator W/Filtered Reserv. through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K961836Maxima Forte Hardshell Venous ReservoirMedtronic Vascular19961—
+2K980935Capiox SX Hardshell ReservoirTerumo Medical Corp.19980—