510(k) Report

Devices descending from K000430

18 later devices reach Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Carmeda… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143073Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT…Medtronic, Inc.20152—
+1K123314Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive SurfaceMedtronic, Inc.201321
+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—
+1K103357LifebridgeLifebridge Medizintechnik AG20100—
+2K172984Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with…Medtronic, Inc.20170—
+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
+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—
+2K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single…Medtronic, Inc.201242
+3K250937Venous Return CannulaeLivaNova USA, Inc.20260—
+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—
+4K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc.20251—
+5K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L.20260—