510(k) Report

Devices descending from K053025

12 later devices reach Jostra HLM Tubing Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092486Vortex Medical Angiovac Cardiopulmonary Bypass CircuitVortex Medical, Inc.200911
+1K080592HLM Tubing Set with Bioline CoatingMaquet Cardiopulmonary, AG20088221
+1K061832Jostra HLM Tubing Sets with Safeline CoatingMaquet Cardiopulmonary, AG20060—
+2K200109OXY-1 SystemAbiomed, Inc.20202Class I
+2K142607AngioVac CircuitAngiodynamics201401
+2K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+2K090533HLM Tubing Set with Softline CoatingMaquet Cardiopulmonary, AG20093—
+2K083794Mecc Set with Bioline CoatingMaquet Cardiopulmonary, AG20090—
+3K223161OXY-1 SystemAbiomed, Inc.20230—
+3K222297CentriMag Pre-connected PackAbbott20220—
+3K133598Cardiohelp SystemMaquet Cardiopulmonary, AG20140Class I
+3K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—