MEDTRONIC PERFUSION SYSTEMS

FDA Device Registration & Listing · Minneapolis, MN, US · Registration 2184009

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2184009
FEI Number
1000116158
Entity Name
MEDTRONIC PERFUSION SYSTEMS
City/State/Country
Minneapolis, MN, US
Establishment Address
7611 Northland Dr, Minneapolis, MN 55428, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Medtronic, Inc. (Owner Number: 2112641)
Owner / Operator Contact Address
710 Medtronic Parkway, Minneapolis, MN 55432, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K060400
PMA Number
N/A

All Registered Proprietary Names

Adapter HMS Control Cannula DLP Coronary Artery Ostial Cannula Affinity Pixie Arterial Filter with Balance Biosurface DLP Cannula Adapter Affinity Minimax ECMO Intersept Affinity 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 Affinity Intersept Minimax ECMO Bio-probe CLAMP CRYOFLEX Cardioblate CryoFlex Surgical Ablation System Probes CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY Cardioblate™ Gemini™ Minimax ECMO Affinity Intersept 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 Connectors Adapters DLP™ Silicone Coronary Artery Ostial Cannulae Cardioblate 49313 Surgical Ablation Pen Cardioblate 49314 XL Surgical Ablation Pen CLOTtrac HR Abnormal Control MYOtherm ECMO Intersept Affinity Minimax DLP Cannula ABLATION PEN 4920501 W/PACING DLP Cannula Bio-Medicus Cannula MYOtherm XP™ Cardioplegia Delivery System with Cortiva™ BioActive Surface SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES BioTrend Affinity 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 Bio-Medicus Performer ACT EASY FILL DEVICE Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface DLP Silicone RCSP Cannula Affinity Fusion Recirculation Line Affinity DLP Cannula 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 Biotherm Affinity Minimax Intersept 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 Bio-probe CATHETER, CANNULA &TUBING, VASCULAR, CARDIOPULMONARY BYPASS Bio-Medicus Life Support Catheter and Introducer Vent Catheter Gauge, Pressure, Coronary, Cardiopulmonary Bypass Cannula Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface autoLog IQ Autotransfusion System Cannula Biotherm Myotherm HMS Control DLP Cannula Cannulae Hepcon HMS Plus MONITOR TEMPERATURE DLP Pressure Monitoring Catheter 540 550M 560 MEDTRONIC BIOMEDICUS BIO-CONSOLE MO Bio-console and Handcrank Bio-Console and Handcrank Thermistor Probe Cannula 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 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Urchin Starfish Octopus Quickflow DPS Distal Perfusion Kit Adapter 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 Balance Biosurface Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface Bio-probe Clearview ANALYZER, HEPARIN, AUTOMATED Tubing, Connectors, and Accessories DLP Phrenic Nerve Pad Cardioblate Diagnostic Kit Cardioblate Generator

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2008-03-14
GGN Plasma, Coagulation Control Hematology Class 2 864.5425 2017-10-05
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-14
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2013-11-08
DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line Cardiovascular Class 2 870.4260 2013-11-08
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-14
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2008-03-14
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2008-03-14
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2017-01-05
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-14
GKN Timer, Clot, Automated Hematology Class 2 864.5400 2008-03-14
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2005-05-31
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2014-09-08
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-14
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2008-03-14
DPT Probe, Blood-Flow, Extravascular Cardiovascular Class 2 870.2120 2008-03-14
OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue General, Plastic Surgery Class 2 878.4400 2013-06-28
GDJ Clamp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2008-03-14
OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue General, Plastic Surgery Class 2 878.4400 2020-09-10
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2008-03-14
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2014-05-27
OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue General, Plastic Surgery Class 2 878.4400 2011-11-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2008-03-14
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2008-03-14
KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Cardiovascular Class 2 870.4360 2011-09-13
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2007-12-27
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2024-09-23
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2024-11-21
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2018-07-01
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2017-01-09
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2017-01-09
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-25
KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Cardiovascular Class 2 870.4360 2000-06-02
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2017-10-05
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2018-04-12
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2008-03-25
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2024-09-23
OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue General, Plastic Surgery Class 2 878.4400 2019-07-03
JBP Activated Whole Blood Clotting Time Hematology Class 2 864.7140 2008-03-14
DTN Reservoir, Blood, Cardiopulmonary Bypass Cardiovascular Class 2 870.4400 2008-03-14
DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass Cardiovascular Class 2 870.4330 2015-04-24
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2008-03-14
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-14
LDF Electrode, Pacemaker, Temporary Cardiovascular Class 2 870.3680 2013-11-12
OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue General, Plastic Surgery Class 2 878.4400 2013-11-12
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-14
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2008-03-14
DTR Heat-Exchanger, Cardiopulmonary Bypass Cardiovascular Class 2 870.4240 2017-03-13
JBP Activated Whole Blood Clotting Time Hematology Class 2 864.7140 2016-09-01
DTY Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass Cardiovascular Class 2 870.4410 2010-05-13
DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line Cardiovascular Class 2 870.4260 2008-03-14
GGN Plasma, Coagulation Control Hematology Class 2 864.5425 2008-03-14
JBP Activated Whole Blood Clotting Time Hematology Class 2 864.7140 2008-03-14
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2012-09-21
JOD Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass Cardiovascular Class 2 870.4270 2012-09-21
DTP Defoamer, Cardiopulmonary Bypass Cardiovascular Class 2 870.4230 2012-09-21
DTN Reservoir, Blood, Cardiopulmonary Bypass Cardiovascular Class 2 870.4400 2012-09-21
DTR Heat-Exchanger, Cardiopulmonary Bypass Cardiovascular Class 2 870.4240 2012-09-21
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2012-09-21
DTS Sucker, Cardiotomy Return, Cardiopulmonary Bypass Cardiovascular Class 2 870.4420 2017-10-05
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2013-02-11
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2025-08-21
DWE Tubing, Pump, Cardiopulmonary Bypass Cardiovascular Class 2 870.4390 2008-03-14
DTN Reservoir, Blood, Cardiopulmonary Bypass Cardiovascular Class 2 870.4400 2008-03-14
KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Cardiovascular Class 2 870.4360 2008-03-14
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-14
DTN Reservoir, Blood, Cardiopulmonary Bypass Cardiovascular Class 2 870.4400 2008-03-14
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-14
DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass Cardiovascular Class 2 870.4220 2013-11-08
GGY Pipette, Diluting Hematology Class 1 864.6160 2006-10-17
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2012-12-18
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-14
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2013-02-12
DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line Cardiovascular Class 2 870.4260 2008-03-14
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-14
OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue General, Plastic Surgery Class 2 878.4400 2024-09-13
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2011-07-06
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2019-10-08
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-14
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-14
KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Cardiovascular Class 2 870.4360 2020-02-07
DWA Control, Pump Speed, Cardiopulmonary Bypass Cardiovascular Class 2 870.4380 2020-02-07
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2003-12-15
OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue General, Plastic Surgery Class 2 878.4400 2019-10-24
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-14
OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue General, Plastic Surgery Class 2 878.4400 2013-11-12
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-14
JOX Analyzer, Heparin, Automated Hematology Class 2 864.5680 2008-03-14
JBP Activated Whole Blood Clotting Time Hematology Class 2 864.7140 2008-03-14
DTN Reservoir, Blood, Cardiopulmonary Bypass Cardiovascular Class 2 870.4400 2013-11-05
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2014-11-20
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2013-05-02
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2019-07-03
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2019-10-24
JOX Analyzer, Heparin, Automated Hematology Class 2 864.5680 2008-03-14
DTR Heat-Exchanger, Cardiopulmonary Bypass Cardiovascular Class 2 870.4240 2008-03-14
DTN Reservoir, Blood, Cardiopulmonary Bypass Cardiovascular Class 2 870.4400 2008-03-14
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2014-05-27
JOD Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass Cardiovascular Class 2 870.4270 2014-12-09
DTP Defoamer, Cardiopulmonary Bypass Cardiovascular Class 2 870.4230 2014-12-09
DTN Reservoir, Blood, Cardiopulmonary Bypass Cardiovascular Class 2 870.4400 2014-12-09
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 1992-12-02
DTN Reservoir, Blood, Cardiopulmonary Bypass Cardiovascular Class 2 870.4400 2008-03-14
DPT Probe, Blood-Flow, Extravascular Cardiovascular Class 2 870.2120 2015-04-24
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2012-06-25
QHW Single Lumen Ecmo Cannula Cardiovascular Class 2 870.4100 2022-02-25
DRA Catheter, Steerable Cardiovascular Class 2 870.1280 2008-03-14
DXS Gauge, Pressure, Coronary, Cardiopulmonary Bypass Cardiovascular Class 2 870.4310 2018-08-16
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-14
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2013-02-07
CAC Apparatus, Autotransfusion Anesthesiology Class 2 868.5830 2018-08-31
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-14
DTR Heat-Exchanger, Cardiopulmonary Bypass Cardiovascular Class 2 870.4240 2008-03-14
GGN Plasma, Coagulation Control Hematology Class 2 864.5425 2008-03-14
JOX Analyzer, Heparin, Automated Hematology Class 2 864.5680 2008-03-14
GFT Protamine Sulphate Hematology Class 2 864.7525 2008-03-14
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2014-01-28
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2015-04-03
JOX Analyzer, Heparin, Automated Hematology Class 2 864.5680 2013-05-01
DWE Tubing, Pump, Cardiopulmonary Bypass Cardiovascular Class 2 870.4390 2008-03-14
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-14
DWA Control, Pump Speed, Cardiopulmonary Bypass Cardiovascular Class 2 870.4380 2000-06-02
DWA Control, Pump Speed, Cardiopulmonary Bypass Cardiovascular Class 2 870.4380 2009-03-23
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2008-03-14
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-14
KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Cardiovascular Class 2 870.4360 2013-11-26
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2024-07-17
DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line Cardiovascular Class 2 870.4260 2024-07-17
DTN Reservoir, Blood, Cardiopulmonary Bypass Cardiovascular Class 2 870.4400 2024-07-17
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2018-07-01
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2016-05-31
DTN Reservoir, Blood, Cardiopulmonary Bypass Cardiovascular Class 2 870.4400 2013-01-14
PZX Left Atrial Appendage Clip, Implantable General, Plastic Surgery Class 2 878.4300 2023-09-26
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2019-10-17
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2014-02-07
MWS Stabilizer, Heart Cardiovascular Class 1 870.4500 2008-03-14
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2008-03-14
OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue General, Plastic Surgery Class 2 878.4400 2019-08-27
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2019-08-27
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2024-08-20
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2023-07-21
DPT Probe, Blood-Flow, Extravascular Cardiovascular Class 2 870.2120 2008-03-14
FQH Lavage, Jet General Hospital Class 2 880.5475 2008-03-14
JBP Activated Whole Blood Clotting Time Hematology Class 2 864.7140 2016-09-01
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2017-11-15
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2008-03-14
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2008-03-14

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medtronic, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
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Other Registrations for Same Entity

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3015192387 CATHWORKS Newport Beach, CA, US
3004185781 Medtronic, Inc. Tempe, AZ, US
3012520654 MEDTRONIC, INC. Billerica, MA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K103464 Medtronic, Inc. PACIFIC XTREME PTCA BALLOON DILATATION CATHETER 2010-12-22
K111339 Medtronic, Inc. HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) 2011-06-08
K915301 Advance Medical Designs, Inc. ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK 1992-12-11
K021022 Instrumentation Laboratory CO HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED) 2002-05-14
K113211 Instrumentation Laboratory CO HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL 2012-01-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-2022 Medtronic Perfusion Systems 2
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Z-0514-2014 Instrumentation Laboratory Co. 2
HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120
Z-0515-2014 Instrumentation Laboratory Co. 2
HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
Z-0516-2014 Instrumentation Laboratory Co. 2
HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320
Z-0021-2018 OriGen Biomedical, Inc. 2
The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.

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1450662 Isomedix Operations, Inc. Libertyville, IL, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2184009. Last updated year: 2026. Please use registration number 2184009 when referencing this establishment in official correspondence.
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