510(k) Report

Devices descending from K023132

16 later devices reach Jostra Mecc System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090006Lifebridge B2T, Model 7001Lifebridge Medizintechnik AG20095—
+1K083794Mecc Set with Bioline CoatingMaquet Cardiopulmonary, AG20090—
+1K053025Jostra HLM Tubing SetMaquet Cardiopulmonary, AG2005122
+2K111384LifebridgeLifebridge Medizintechnik AG20110—
+2K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+2K103357LifebridgeLifebridge Medizintechnik AG20100—
+2K092486Vortex Medical Angiovac Cardiopulmonary Bypass CircuitVortex Medical, Inc.200911
+2K080592HLM Tubing Set with Bioline CoatingMaquet Cardiopulmonary, AG20088221
+2K061832Jostra HLM Tubing Sets with Safeline CoatingMaquet Cardiopulmonary, AG20060—
+3K200109OXY-1 SystemAbiomed, Inc.20202Class I
+3K142607AngioVac CircuitAngiodynamics201401
+3K133598Cardiohelp SystemMaquet Cardiopulmonary, AG20140Class I
+3K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—
+3K090533HLM Tubing Set with Softline CoatingMaquet Cardiopulmonary, AG20093—
+4K223161OXY-1 SystemAbiomed, Inc.20230—
+4K222297CentriMag Pre-connected PackAbbott20220—