510(k) Report

Devices descending from K935717

15 later devices reach Affinity Venous Reservior Bag through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031700Medtronic Resting Heart System, Model AAR1000 and 711Medtronic Perfusion Systems2003131
+1K981628Bard Quantum SVR Model Number H-6440VRC.R. Bard, Inc.19980—
+2K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc.20115—
+2K090006Lifebridge B2T, Model 7001Lifebridge Medizintechnik AG20095—
+2K082321Terumo Rocsafe Hybrid Perfusion SystemTerumo Cardiovascular Systems Corp.20090—
+3K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single…Medtronic, Inc.201242
+3K111384LifebridgeLifebridge Medizintechnik AG20110—
+3K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+3K103357LifebridgeLifebridge Medizintechnik AG20100—
+4K250937Venous Return CannulaeLivaNova USA, Inc.20260—
+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—
+5K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc.20251—
+6K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L.20260—