510(k) Report

Devices descending from K924642

63 later devices reach Medtronic Bio-Medicus Femoral Cannula/Introducer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K13329315 FR. Tandemheart Arterial CannulaCardiacassist, Inc.20140—
+1K133236Tandemheart Femoral Venous Cannula SetCardiacassist, Inc.20148—
+1K131666Arterial HLS Cannula 13 FR Non-Coated, with Bioline Coating and with Softline CoatingMaquet Cardiopulmonary, AG201303
+1K120543Tandemheart Femoral Arterial Cannula SetCardiacassist, Inc.20121—
+1K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc.20115—
+1K102532HLS Cannula Non-Coated, with Bioline Coating and with Softline CoatingMaquet Cardiopulmonary, AG20111—
+1K063723Impella Recover LP 2.5 Percutaneous Cardiac Support SystemAbiomed, Inc.20087—
+1K052570Tandemheart Transseptal Cannula Set-EF, Model 5140-6221Cardiacassist, Inc.200691
+1K031827Ultraflex Venous Cannula, Model 970XX and CB970XXMedtronic Perfusion Systems200315—
+1K012512Setpoint Endovascular Temperature Management SystemRadiant Medical200227—
+2K162214Protek Solo 24 Fr Venous Cannula SetCardiacassist, Inc.201601
+2K140999Tandemheart Veno-Venous CannulaCardiacassist, Inc.20147—
+2K112892Impella 2.5 Plus CatheterAbiomed, Inc.20120—
+2K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single…Medtronic, Inc.201242
+2K093801Impella ControllerAbiomed, Inc.20101—
+2K083111Impella 5.0 Catheter FamilyAbiomed, Inc.200931
+2K082425Tandemheart Transseptal Cannula- EF 72Cardiacassist, Inc.20080—
+2K071358Reprieve Endovascular Temperature Therapy SystemRadiant Medical20070—
+2K063405Reprieve Endovascular Temperature Therapy SystemRadiant Medical20071—
+2K052081Remote Access Perfusion (Rap) Femoral Venous CannulaEstech, Inc.200581
+2K033623Celsius Control SystemInnercool Therapies, Inc.20042—
+2K030421Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp.2003154
+2K024327Setpoint Endovascular Temperature ProbeRadiant Medical20031—
+2K023914Coaxia Flocontrol CatheterCoaxia, Inc.20036—
+2K022366Celsius Control SystemInnercool Therapies200316—
+3K250937Venous Return CannulaeLivaNova USA, Inc.20260—
+3K250283RAP Femoral Venous CannulaeLivaNova USA, Inc.20250—
+3K232480ProtekDuo Veno-Venous Cannula SetsCardiacassist, Inc.20230—
+3K160257PROTEK Duo 31 Fr. Veno-Venous Cannula SetCardiacassist, Inc.201651
+3K140165MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage…Medtronic, Inc.20142—
+3K110845Impella Controller with Flow ControlAbiomed, Inc.20110—
+3K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+3K090970Flocontrol , Model 1028Coaxia, Inc.20091—
+3K080908Innercool Therapies, Inc., Rapidblue SystemInnercool Therapies, Inc.- A Delaware Corporation200811
+3K080700Duoflo CatheterThermopeutix, Inc.20083—
+3K081936Solex Catheter, Model SL2593Alsius Corp.20085—
+3K060101Estech Aortic Easy Flow CannulaEndoscopic Technologies, Inc.20066—
+3K052443Icy Catheter, Model IC-3893AAlsius Corp.20058—
+3K051912Cool Line Catheter Kit, Models CL-2085B, CL-2295A; Icy Catheter Kit, Model IC-3585A…Alsius Corp.20050—
+3K042388Radiant Medical Endocatheter Temperature ProbeRadiant Medical20040—
+4K250610Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)Sorin Group Italia S.R.L.20250—
+4K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc.20251—
+4K203067Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F…Qura S.R.L20212—
+4K192786Gatekeeper Balloon CatheterArch Catheter, LLC20200—
+4K181150ProtekDuo Mini Veno-Venous Cannula SetCardiacassist, Inc.20181—
+4K152946TempedySeiratherm GmbH20160—
+4K141139Solex Intravascular Heat Exchange CatheterZoll Circulation20144—
+4K133598Cardiohelp SystemMaquet Cardiopulmonary, AG20140Class I
+4K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—
+4K112219Tapas CatheterThermopeutix, Inc.20111—
+4K101987Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter…Zoll Circulation20106—
+4K093847Duflo Catheter (Heparin Coated)Thermopeutix, Inc.20100—
+4K091542Estech Easyflow Cannula with GuidewireEndoscopic Technologies, Inc. D/B/A Estech20091—
+4K070161Quattro Catheter Model IC4593Alsius Corp.20077—
+5K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L.20260—
+5K221353Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F…Qura S.R.L20221—
+5K153226Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitZoll Circulation, Inc.201634
+5K150046Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular…Zoll Circulation, Inc.2015421
+5K141175Renovocath RC120Renovorx, Inc.201401
+6K241248Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)Spectrum Medical S.R.L.20240—
+6K213031Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc.20212—
+7K223746Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc.20230—
+7K220008Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc.20221—