510(k) Report

Devices descending from K845045

18 later devices reach Venous Return Catheter SS-1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single…Medtronic, Inc.201242
+1K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc.20115—
+1K031827Ultraflex Venous Cannula, Model 970XX and CB970XXMedtronic Perfusion Systems200315—
+1K022272Malleable Single Stage Venous Cannula, Models 68112-68140 (15 Total Codes)Medtronic Cardiac Surgical Products200373
+2K250937Venous Return CannulaeLivaNova USA, Inc.20260—
+2K140165MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage…Medtronic, Inc.20142—
+2K052081Remote Access Perfusion (Rap) Femoral Venous CannulaEstech, Inc.200581
+2K033264Malleable Single Stage Venous Cannula with Carmeda Bioactive Surface, Model CB681XX SeriesMedtronic Perfusion Systems200361
+3K250283RAP Femoral Venous CannulaeLivaNova USA, Inc.20250—
+3K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc.20251—
+3K060101Estech Aortic Easy Flow CannulaEndoscopic Technologies, Inc.20066—
+4K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L.20260—
+4K250610Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)Sorin Group Italia S.R.L.20250—
+4K091542Estech Easyflow Cannula with GuidewireEndoscopic Technologies, Inc. D/B/A Estech20091—
+4K083111Impella 5.0 Catheter FamilyAbiomed, Inc.200931
+5K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+6K133598Cardiohelp SystemMaquet Cardiopulmonary, AG20140Class I
+6K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—