510(k) Report

Devices descending from K100631

9 later devices reach Affiity CP Centrifugal Blood Pump through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132712Affinity CP Centrifugal Blood Pump with or Without Coating, Affinity CP AdapterMedtronic, Inc.20130—
+1K111658Affinity CP Centrifugal Bllod Pump with Carmeda Bioactive SurfaceMedtronic, Inc.20117—
+1K111657Affinity CP Centrifugal Blood Pump with Balance BiosurfaceMedtronic, Inc.20111—
+2K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc.20115—
+3K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single…Medtronic, Inc.201242
+4K250937Venous Return CannulaeLivaNova USA, Inc.20260—
+4K140165MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage…Medtronic, Inc.20142—
+5K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc.20251—
+6K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L.20260—