510(k) Report

Devices descending from K090533

3 later devices reach HLM Tubing Set with Softline Coating through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+2K133598Cardiohelp SystemMaquet Cardiopulmonary, AG20140Class I
+2K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—