510(k) Report

Devices descending from K012538

14 later devices reach Tubing and Connectors with Trillium Biopassive Surface through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113845Tubing, Conmnectors, and Accessories Wit Balance BiosurfaceMedtronic, Inc.201271
+1K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc.20115—
+2K151523Uncoated Tubing and Connector ComponentsMedtronic, Inc.20154—
+2K122913Affinity Fusion Recirculation Line Model RCL841Medtronic, Inc.20120—
+2K122811Connector Components with Balance BiosurfaceMedtronic, Inc.201251
+2K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single…Medtronic, Inc.201242
+3K250937Venous Return CannulaeLivaNova USA, Inc.20260—
+3K171308Tubing PackMedtronic, Inc.201731
+3K140165MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage…Medtronic, Inc.20142—
+4K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc.20251—
+4K171979Tubing PackMedtronic, Inc.2017225
+5K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L.20260—
+5K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart Reactors20260—
+5K213540Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia SetQura S.R.L20220—