510(k) Report

Devices descending from K031827

15 later devices reach Ultraflex Venous Cannula, Model 970XX and CB970XX through their predicates, nearest generation first.

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