510(k) Report

Devices descending from K936003

14 later devices reach Affinity CVR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc.20115—
+1K021287Trillium Affinity NT Cardiotomy Venous Reservoir, Models 540T, 541TTMedtronic Perfusion Systems2002111
+1K961836Maxima Forte Hardshell Venous ReservoirMedtronic Vascular19961—
+2K100645Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or Balance BiosurfaceMedtronic, Inc.20124—
+2K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single…Medtronic, Inc.201242
+2K980935Capiox SX Hardshell ReservoirTerumo Medical Corp.19980—
+3K250937Venous Return CannulaeLivaNova USA, Inc.20260—
+3K172984Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with…Medtronic, Inc.20170—
+3K160091Temperature Probe, Affinity Temperature ProbeMedtronic, Inc.20160—
+3K141233Affinity Pixie Oxygenation System with; Carmeda Bioactive Surface, Balance BiosufaceMedtronic, Inc.20141—
+3K140165MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage…Medtronic, Inc.20142—
+3K123448Affinity Flexible Luer Lock Adapter with Balance Biosurface, Affinity Flexible Luer Lock…Medtronic, Inc.20120—
+4K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc.20251—
+5K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L.20260—