510(k) Report

Devices descending from K800178

28 later devices reach Extracorp.'S Intersept Cus. Tubing PK. through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113845Tubing, Conmnectors, and Accessories Wit Balance BiosurfaceMedtronic, Inc.201271
+1K053025Jostra HLM Tubing SetMaquet Cardiopulmonary, AG2005122
+1K012538Tubing and Connectors with Trillium Biopassive SurfaceMedtronic Vascular2001145
+2K151523Uncoated Tubing and Connector ComponentsMedtronic, Inc.20154—
+2K122913Affinity Fusion Recirculation Line Model RCL841Medtronic, Inc.20120—
+2K122811Connector Components with Balance BiosurfaceMedtronic, Inc.201251
+2K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc.20115—
+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
+3K171308Tubing PackMedtronic, Inc.201731
+3K142607AngioVac CircuitAngiodynamics201401
+3K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single…Medtronic, Inc.201242
+3K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+3K090533HLM Tubing Set with Softline CoatingMaquet Cardiopulmonary, AG20093—
+3K083794Mecc Set with Bioline CoatingMaquet Cardiopulmonary, AG20090—
+4K250937Venous Return CannulaeLivaNova USA, Inc.20260—
+4K223161OXY-1 SystemAbiomed, Inc.20230—
+4K222297CentriMag Pre-connected PackAbbott20220—
+4K171979Tubing PackMedtronic, Inc.2017225
+4K133598Cardiohelp SystemMaquet Cardiopulmonary, AG20140Class I
+4K140165MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage…Medtronic, Inc.20142—
+4K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—
+5K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart Reactors20260—
+5K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc.20251—
+5K213540Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia SetQura S.R.L20220—
+6K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L.20260—