BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MEDTRONIC PERFUSION SYSTEMS

    Reg #: 2184009 · FEI: 1000116158 · Expires 2026
    View on FDA
    Products
    46
    Proprietary Names
    240
    Establishment Types
    3
    Classifications
    46

    Registration Details

    Registration Name
    MEDTRONIC PERFUSION SYSTEMS
    Registration Number
    2184009
    FEI Number
    1000116158
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7611 Northland Dr
    City
    Minneapolis
    State
    MN
    ZIP
    55428
    Country
    US

    Regulatory Submissions

    510(k) Number
    K900994

    Owner / Operator

    Firm Name
    Medtronic, Inc.
    Operator Number
    2112641
    Address
    710 Medtronic Parkway
    City
    Minneapolis
    State
    MN
    Postal Code
    55432
    Country
    US

    Products

    Device Name Product Code
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Plasma, Coagulation Control GGN
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF
    Filter, Blood, Cardiopulmonary Bypass, Arterial Line DTM
    Oxygenator, Cardiopulmonary Bypass DTZ
    Timer, Clot, Automated GKN
    Guide, Surgical, Instrument FZX
    Probe, Blood-Flow, Extravascular DPT
    Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue OCL
    Clamp, Surgical, General & Plastic Surgery GDJ
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    System, Multipurpose For In Vitro Coagulation Studies JPA
    Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type KFM
    Continuous Measurement Thermometer FLL
    Activated Whole Blood Clotting Time JBP
    Reservoir, Blood, Cardiopulmonary Bypass DTN
    Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass DRY
    Electrode, Pacemaker, Temporary LDF
    Catheter, Percutaneous DQY
    Heat-Exchanger, Cardiopulmonary Bypass DTR
    Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass DTY
    Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass JOD
    Defoamer, Cardiopulmonary Bypass DTP
    Sucker, Cardiotomy Return, Cardiopulmonary Bypass DTS
    Tubing, Pump, Cardiopulmonary Bypass DWE
    Console, Heart-Lung Machine, Cardiopulmonary Bypass DTQ
    Pipette, Diluting GGY
    Device, Vascular, For Promoting Embolization KRD
    Control, Pump Speed, Cardiopulmonary Bypass DWA
    Container, Specimen, Sterile FMH
    Analyzer, Heparin, Automated JOX
    Instruments, Surgical, Cardiovascular DWS
    Single Lumen Ecmo Cannula QHW
    Catheter, Steerable DRA
    Gauge, Pressure, Coronary, Cardiopulmonary Bypass DXS
    Apparatus, Autotransfusion CAC
    Protamine Sulphate GFT
    Catheter, Electrode Recording, Or Probe, Electrode Recording DRF
    Left Atrial Appendage Clip, Implantable PZX
    Stabilizer, Heart MWS
    Lavage, Jet FQH
    Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
    Container, I.V. KPE
    Apparatus, Electrosurgical HAM
    Retractor GAD
    Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass DTW

    Proprietary Names

    Adapter HMS Control Cannula DLP Coronary Artery Ostial Cannula Affinity Pixie Arterial Filter with Balance Biosurface DLP Cannula Affinity Minimax ECMO Intersept Gundry RSCP ACT EEA TAID Guide Pin; Introducer Tool DRILL GUIDES GUIDE WIRES (PINS) LAA Selection Guide Cardiopulmonary bypass vascular catheter, cannula, or tubing DLP Aortic Root Cannula Bio-probe CLAMP CRYOFLEX Cardioblate CryoFlex Surgical Ablation System Probes CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY Cardioblate™ Gemini™ OVAL MC2Two-Stage Venous Cannula Thin Wall Two-Stage Venous Cannula MC2Two-Stage Venous Cannula MC2XThree-Stage Venous Cannula ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Dispersive Electrode Adapter RACT Cartridge Affinity CP Centrifugal Bloop Pump w/ Balance Biosurface Myocardial Needle Temperature Probe Reusable and Disposable Temperature Probes DLP™ Silicone Coronary Artery Ostial Cannulae Affinity Fusion™ Oxygenator System Affinity Pixie™ Oxygenation System Cannulae, Femoral Venous 1-Piece, BioMedicus Bio-Medicus BIOPUMP (VARIOUS MODELS) Adaptors Quickflow DPS Vacuum Relief Valve Distal Perfusion Kit Connectors Tubing Pack Adapters Cardioblate 49313 Surgical Ablation Pen Cardioblate 49314 XL Surgical Ablation Pen CLOTtrac HR Abnormal Control MYOtherm ABLATION PEN 4920501 W/PACING Bio-Medicus Cannula MYOtherm XP™ Cardioplegia Delivery System with Cortiva™ BioActive Surface SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES BioTrend CLOTtrac HTC Pixie Oxygenation and CVR Combo, Balance coated Pixie Oxygenator, Balance coated Pixie Oxygenator, Carmeda coated Affinity Temperature Probe Pixie Oxygenation and CVR Combo, Carmeda coated DLP Suction Tube, 6 1/2, Frazier Tip, 6 Fr DLP Suction Tube DLP Single Stage Venous Cannula MC2X™ Three-Stage Venous Cannula MC2™ Two-Stage Venous Cannula MONITOR TEMPERATURE Biotherm Myotherm BIO-PUMP SELECT EL Reservoir Performer ACT EASY FILL DEVICE Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface DLP Silicone RCSP Cannula Affinity Fusion Recirculation Line Cardioblate Gemini-s 49351 Surgical Ablation Device Cardioblate Gemini-s 49260 Surgical Ablation Device FILTER,O2,BI-DIRECTIONAL,CAP- DUST,3/16IN,GREEN,VENT,ST Affinity NT™ Oxygenator with Balance Biosurface MC2 Multistage Carpentier Bi-Caval Femoral Cannula Medtronic External Drive Motor Affinity™ CP Centrifugal Blood Pump Container Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue DLP Air Aspirating Needle CARDIOBLATE GEMINI Select 3D Heparin Assay 4 CH LR-ACT FUSION CV-SH Cannulae, Fem Arterial 1-Piece, Bio-Medicus CV-SH Cannulae, Femoral Venous 1-Piece, BioMedicus DLP PVC RCSP Cannulae Auto-Inflate Cuff, 12 in. (30.5 cm) length - Smooth preformed Cuff, short fluted, bullet nosed DLP Silicone RCSP Cannulae Auto-Inflate Cuff 12.5in. (31.8 cm) length- WW Body/Smooth preformed Cuff -guidewire Stylet/ DLP PVC RCSP Cannulae Auto-Inflate Cuff, 10 in. (25.4 cm) length - Smooth preformed Cuff, short fluted tip, and integ DLP PVC RCSP Cannulae Auto-Inflate Cuff 11 in. (27.9 cm) length - Smooth preformed Cuff, Multi-port tip, and integral DLP PVC RCSP Cannulae Auto-Inflate Cuff, 12.5 in. (31.8cm) length - Ridged preformed Silicone Cuff, short fluted, bulle DLP Silicone RCSP Cannulae Auto-Inflate Cuff 12.5in. (31.8 cm) length-WW Body/Smooth preformed Cuff -Solid Stylet/Tru-T DLP PVC RCSP Cannulae Auto-Inflate Cuff, 12.5 in. (31.8 cm) length - Smooth preformed Cuff, fluted, bullet nosed tip, a DLP Silicone RCSP Cannulae Auto-Inflate Cuff 12.5in. (31.8 cm) length - WW Body/Smooth preformed Cuff - Solid Stylet DLP Silicone RCSP Cannulae Auto-Inflate Cuff 12.5in. (31.8 cm) length- WW Body/Ridged preformed Cuff- Solid Stylet/Tru- DLP Silicone RCSP Cannulae Auto-Inflate Cuff 12.5in. (31.8 cm) length - WW Body/Smooth preformed Cuff - Guidewire Sty DLP Silicone RCSP Cannulae Auto-Inflate Cuff 12.5in. (31.8 cm) - WW Body/Ridged preformed Cuff- guidewire Stylet/Tru-To DLP PVC RCSP Cannulae Auto-Inflate Cuff 11 in. (27.9 cm) length - Smooth preformed Cuff, multi-port tip, and integral DLP PVC RCSP Cannulae Auto-Inflate Cuff, 12.5 in. (31.8 cm) length -Ridged preformed Silicone Cuff, short fluted, bulle DLP PVC RCSP Cannulae Auto-Inflate Cuff, 12.5 in. (31.8 cm) length - Ridged preformed Silicone Cuff, short fluted, bull DLP PVC RCSP Cannulae Auto-Inflate Cuff, 12.5 in. (31.8 cm) length - Smooth preformed Cuff, fluted, bullet nosed tip, Affinity Pixie Oxygenator with Cortiva BioActive Surface Affinity Pixie Oxygenator with Balance Biosurface Affinity NT™ Oxygenator with Cortiva™ BioActive Surface Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with Trillium™ Biosurface Affinity NT™ Integrated Uncoated CVR/Oxygenator with Cortiva™ BioActive Surface Affinity NT™ Oxygenator Heparin Assay 6 CH Resting Heart DLP Retrograde Coronary Sinus Cannula Without Pressure Monitoring Line DLP Retrograde Coronary Sinus Perfusion Cannulae Without Pressure Monitoring Lumen Affinity Pixie CVR MITRAL COLLAR AND TIE Actuators Rotation Tool Kit AORTIC CUFF Universal Mounting Rail pinch on tool MEDIUM BLADE SET TOOL Lead Accessory Kit Adjustable Slitter Implant Tool Kit ATRIAL LIFT SYSTEM Accessory Port ATS Medical Thoracic Port System EXTRA LG BLADE SET TOOL INTERCOSTAL RETRACTOR SYSTEM SUTURE BELT LARGE BLADE SET TOOL STERILIZATION TRAY TOOL RETRACTOR RACK TOOL SMALL BLADE SET TOOL Mounting Rail Universal II Slitter Affinity CVR CATHETER, CANNULA &TUBING, VASCULAR, CARDIOPULMONARY BYPASS Bio-Medicus Life Support Catheter and Introducer Vent Catheter Gauge, Pressure, Coronary, Cardiopulmonary Bypass Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface autoLog IQ Autotransfusion System Cannulae Hepcon HMS Plus DLP Pressure Monitoring Catheter 540 550M 560 MEDTRONIC BIOMEDICUS BIO-CONSOLE MO Bio-console and Handcrank Bio-Console and Handcrank Thermistor Probe Bio-Pump BP50 Affinity CP Centrifugal Blood Pump Emergency Hand Crank External Motor Affinity CP Adapter Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Balance™ Biosurface Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance™ Biosurface Cannulae, Femoral, Insertion Kits Temperature Probe, Affinity Temperature Probe Affinity Fusion Cadriotomy/Venous Reservoir with Balance Biosurface LAA Exclusion System Bio-MedicusTM Insertion Kit Urchin Starfish Octopus Cardioblate BP2 Surgical Ablation Device Cardioblate LP Surgical Ablation Device Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir Affinity Fusion Oxygenator with Integrated Arterial Filter and Cortiva™BioActive Surface and Cardiotomy/ Venous Reservoi Affinity Fusion Oxygenator with Integrated Arterial Filter and Cortiva™ BioActive Surface Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface Clearview ANALYZER, HEPARIN, AUTOMATED Tubing, Connectors, and Accessories DLP Phrenic Nerve Pad Cardioblate Diagnostic Kit Cardioblate Generator Autolog Autotransfusion CLOTtrac CWB Affinity CP Centrifugal Pump Intersept Filtered Cardiotomy Reservoir DLP Suction Tube, 6 1/2, Frazier Tip, 6 Fr. Affinity® Pediatric Arterial Filter Affinity Pixie™ Arterial Filter with Balance™ Biosurface Remote Control Foot Switch Dispersive Electrode Cable Cardioblate Surgical Abl Generator Cardioblate Surgical Ablation Pen MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface and MYOtherm XP Cardioplegia Delivery System Uncoated Affinity Fusion™ Oxygenator with Integrated Arterial Filter with Balance™ Biosurface Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cortiva™ BioActive Surface Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cortiva™ BioActive Surface and Cardiotomy/Venous Reservo CLOTtrac RCSP DLP Rapid Prime Set, 14 Affinity Aterial Filter with Balance Biosurface Cardioblate Gemini Uncoated MYOtherm XP Cardioplegia Delivery Systems, Non-Sterile MYOtherm XP with Cortiva BioActive Surface, Sterile Uncoated MYOtherm XP Cardioplegia Delivery Systems, Sterile MYOtherm XP with Cortiva BioActive Surface, Non-Sterile EOPA 3D ClearView Intracoronary Shunts Bio-Medicus" Adult Cannula Kit PRESSURE DISPLAY BOX DLP Pericardial Sump EOPA Affinity CP Centrifugal Blood Pump w/ Carmeda Bioactive Surf EOPA 3D Arterial Cannula Cryoflex Signature ABLT PEN 49205YN W/PACE OUS18L 68000 CARDIOBLATE MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT AUTOLOG DLP Tourniquet Set, Pediatric CONSOLE, RR5100052 RECON PCPB RETRACTOR THORATRAK MICS RETRACTOR SYSTEM Autolog TRI-OPTIC MEASUREMENT Medtronic Performer CPB System with Level Sensing System (Level Sensor [LS100] and Level Sensing Tape [LST]) Medtronic Bio Console 560 System with Level Sensing System (level Sensor [LS100] and Level Sensing Tape [LST]) EGM Cable Cardioblate MAPS Cardioblate XL Surg Abl Pen Cardioblate Surg Abl System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Manufacture Device in the United States for Export Only