510(k) Report

Devices descending from K973760

35 later devices reach Affinity Hollow Fiber Oxygenator with Trillium Biopassive Surface through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143073Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT…Medtronic, Inc.20152—
+1K122827Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface Model…Medtronic, Inc.20122—
+1K100645Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or Balance BiosurfaceMedtronic, Inc.20124—
+1K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc.20115—
+1K111384LifebridgeLifebridge Medizintechnik AG20110—
+1K103357LifebridgeLifebridge Medizintechnik AG20100—
+1K060509Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with Heparin CoatingTyco Healthcare Group200674
+1K050109Trillium Biopump Plus, Model BPX80TMedtronic Perfusion Systems20056—
+1K033468Affinity 20U Arterial Filter with Trillium BiosurfaceMedtronic Perfusion Systems20037—
+1K012743Trillium Tri-Optic Measurement Cell, Model TMC 25T, TMC38 T, TMC 50TMedtronic Perfusion Systems20017—
+1K011864Trillium Myotherm XP Cardioplegia Delivery System, Models 41, 41-BMedtronic Vascular20018—
+2K172984Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with…Medtronic, Inc.20170—
+2K162958MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP…Medtronic, Inc.20171—
+2K162896Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium BiosurfaceMedtronic, Inc.20160—
+2K162016Affinity NT Oxygenator with Cortiva BioActive SurfaceMedtronic, Inc.20160—
+2K160091Temperature Probe, Affinity Temperature ProbeMedtronic, Inc.20160—
+2K142784Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface…Medtronic, Inc.201411
+2K133157Tri-Optic Measurement Cell; with Balance Biosurface, with Carmeda Bioactive Surface…Medtronic, Inc.20140—
+2K141233Affinity Pixie Oxygenation System with; Carmeda Bioactive Surface, Balance BiosufaceMedtronic, Inc.20141—
+2K123448Affinity Flexible Luer Lock Adapter with Balance Biosurface, Affinity Flexible Luer Lock…Medtronic, Inc.20120—
+2K122760Affinity AF100 Arterial Filter with Balance BiosurfaceMedtronic, Inc.20120—
+2K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single…Medtronic, Inc.201242
+2K112477Palindrome H, SI, Hsi Chronic CatheterCovidien20115Class I
+2K06267114.5 FR Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve…Kendall2006624
+3K250937Venous Return CannulaeLivaNova USA, Inc.20260—
+3K240190MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP…Medtronic20240—
+3K172626Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with…Medtronic, Inc.20170—
+3K140165MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage…Medtronic, Inc.20142—
+3K123196Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic Catheter…Covidien20134Class I
+4K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc.20251—
+4K140884Symetrex Long Term Hemodialysis CatheterPhase One Medical20143—
+5K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L.20260—
+5K171618Symetrex Long Term Hemodialysis CatheterMedcomp (Dba Medical Components, Inc.)20172—
+6K202176Symetrex LTHD Catheter, Symetrex LTHD Catheter with SideholesMedical Components, Inc. (dba MedComp)20200—
+6K17366715.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm…Medical Components, Inc. (dba MedComp)20181—