510(k) Report

Devices descending from K080592

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200109OXY-1 SystemAbiomed, Inc.20202Class I
+1K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+1K090533HLM Tubing Set with Softline CoatingMaquet Cardiopulmonary, AG20093—
+1K083794Mecc Set with Bioline CoatingMaquet Cardiopulmonary, AG20090—
+2K223161OXY-1 SystemAbiomed, Inc.20230—
+2K222297CentriMag Pre-connected PackAbbott20220—
+2K133598Cardiohelp SystemMaquet Cardiopulmonary, AG20140Class I
+2K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—