510(k) Report

Devices descending from K000379

8 later devices reach Modofication to Afffinity 38 Micro Arterial Blood Filter with Carmeda… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc.20115—
+1K071253Affinity Pediatric Arterial Filter, Model S4014 and with Carmeda Bioactive Surface…Medtronic Vascular200772
+2K251744Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial…Medtronic20260—
+2K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single…Medtronic, Inc.201242
+3K250937Venous Return CannulaeLivaNova USA, Inc.20260—
+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—