510(k) Report

Devices descending from K072583

2 later devices reach Plegiox Cardioplegia Heat Exchanger, with Safeline Coating, Model (S) CHX30… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090555Plegiox Cardioplegia Heat Exchanger with Softline Coating, Model Bio-CHX 30Maquet Cardiopulmonary, AG200911
+2K112360Quadrox-I Microporporous Membrane Oxgenator Series and Qudrox-ID Diffusion Membrane…Maquet Cardiopulmonary, AG2011012