510(k) Report

Devices descending from K090555

1 later device reach Plegiox Cardioplegia Heat Exchanger with Softline Coating, Model Bio-CHX 30 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112360Quadrox-I Microporporous Membrane Oxgenator Series and Qudrox-ID Diffusion Membrane…Maquet Cardiopulmonary, AG2011012