Medtronic Mexico S. de R.L. de CV

FDA Device Registration & Listing · Tijuana Baja California, MX · Registration 9617601

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
9617601
FEI Number
3002534070
Entity Name
Medtronic Mexico S. de R.L. de CV
City/State/Country
Tijuana Baja California, MX
Establishment Address
Av. Paseo Cucapah 10510 El Lago, Tijuana Baja California C.P. 22210, MX
Establishment Type(s)
Manufacture Medical Device
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
K092177
PMA Number
N/A

All Registered Proprietary Names

Bio-Medicus Cannula Bio-MedicusTM Insertion Kit Adapter Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir Cannula Simulus Flexible Annuloplasty Band CoreValve Evolut PRO System Medtronic CoreValve System CoreValve Evolut R System CoreValve Evolut PRO+ System Evolut FX+ System Medtronic Evolut FX System SimuPlus, SimuForm Tubing Pack Carpentier Bi-Caval Femoral Cannula OVAL MC2Two-Stage Venous Cannula Thin Wall Two-Stage Venous Cannula MC2Two-Stage Venous Cannula MC2XThree-Stage Venous Cannula BIO-PUMP Axium Detachable Coil System DLP Aortic Root Cannula DLP Pressure Monitoring Catheter Affinity Pixie Arterial Filter with Balance Biosurface Cannulae, Femoral Venous 1-Piece, BioMedicus Kyphon Xpander II Inflatable Bone Tamp Carpentier Bi-Caval Femoral Cannula Tri-Ad Adams Annuloplasty Ring Becker External Drainage and Monitoring System PS MEDICAL BIOGLIDE CSF Admiral Xtreme PTA Balloon Dilatation Catheter Admiral Xtreme PTA Balloon Catheter Phenom Catheters Torclip Pacemaker Repair Kit Tri-Ad Adams Annuloplasty Ring Achieve Cannula Preset Needles KyphX 11 Gauge Bone Access Needle Coaxial Aspiration Needles ORO-TRACHEAL INJECTOR NEEDLE Pacific Plus PTA Catheter MEDTRONIC PS MEDICAL EXACTA DRAINAGE SYSTEM POLE CLAMP MEDTRONIC PS MEDICAL EXACTA DRAINAGE SYSTEM KyphX Bone Biopsy Device Exacta External Drainage and Monitoring System (EDMS) Harmony Transcatheter Pulmonary Valve System DLP Single Stage Venous Cannula Intersept Filtered Cardiotomy Reservoir Valiant Thoracic Stent Graft System Cannula INTRACRANIAL PRESSURING MONITORING SYSTEM Biotherm Myotherm Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface Freezor cardiac cryoablation catheter Freezor MAX Surgical cryoablation catheter Freezor Xtra Surgical cardiac cryoablation catheter Cryoconsole Freezor Xtra cardiac cryoablation catheter ECG Cable Coaxial Cable Nitron Remote Nitron CryoConsole DLP Cannula Amphirion Deep 014" OTW PTA Balloon Catheter Amphirion Deep PTA Catheter DLP Cannula Select 3D Cement, Bone BECKER EXTERNAL DRAINAGE/MONITOR SYSTEM LUMBAR CATHETER Pulmonary Valve Ensemble Intersept Affinity ECMO Minimax 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 DLP Cannula Affinity® Pediatric Arterial Filter Affinity Pixie™ Arterial Filter with Balance™ Biosurface NC Euphora" Rapid Exchange Balloon Dilatation Catheter Autolog Autotransfusion Bio-Medicus Life Support Catheter and Introducer Signature Bio-Medicus EL Reservoir DLP Cannula 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 Pacific Xtreme PTA Balloon Dilatation Catheter Minimax ECMO Affinity Intersept DLP Cannula Affinity Fusion™ Oxygenator with Integrated Arterial Filter with Balance™ Biosurface Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance™ Biosurface Affinity NT™ Integrated Uncoated CVR/Oxygenator with Cortiva™ BioActive Surface Affinity NT™ Oxygenator with Cortiva™ BioActive Surface Affinity NT™ Oxygenator Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with Trillium™ Biosurface Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® 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 Autolog Autotransfusion Connectors Adapters Affinity Simulus Flexible Annuloplasty Ring Cannula MEDTRONIC PS MEDICAL EXTERNAL DRAINAGE AND MONITORING VENTRICULAR CATHETER MONITOR TEMPERATURE Autolog Medtronic External Drainage and Monitoring System (EDMS) Simulus Adjustable Annuloplasty Band Medtronic External Drive Motor Affinity™ CP Centrifugal Blood Pump DLP Cannula Quickflow DPS Distal Perfusion Kit Adapter Bio-Medicus DLP Phrenic Nerve Pad EL Reservoir Bio-Medicus" Adult Cannula Kit Simulus Semi-Rigid Annuloplasty Band Simplici-T DLP Pericardial Sump DLP Suction Tube, 6 1/2, Frazier Tip, 6 Fr DLP Suction Tube Sprinter Legend RX Sprinter Over-the-Wire NC Sprinter RX NC Stormer Over-the-Wire Simulus Adjustable Annuloplasty Ring Pacific Plus PTA Catheter Bio-Pump BP50 Affinity CP Centrifugal Blood Pump Emergency Hand Crank External Motor Affinity CP Adapter Simulus Semi-Rigid Annuloplasty Ring DLP Silicone RCSP Cannula Tubing, Connectors, and Accessories Vent Catheter SELECT Amphirion Deep PTA Catheter Amphirion Deep 014" OTW PTA Balloon Catheter (Balloon Extension) Amphirion Deep 014” OTW PTA Balloon Catheter MICRO-FRANCE Manual Surgical Instr MULTIPLE Manual Surgical Instruments KyphX Handle; Introducer XOMED Visualase DUET External Drainage And Monitoring System Medtronic DUET External Drainage And Monitoring System DUET DUET EDMS Cannulae Freezor MAX cardiac cryoablation catheter Arctic Front Advance cardiac cryoablation catheter Arctic Front Advance ProTM CG Future Ring Duran Ancore Band Duran Ancore Ring 6F Launcher Guiding Catheter DLP Cannula Euphora Rapid Exchange Balloon Dilatation Catheter VitalFlow™ Set with Balance™ Biosurface MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface and MYOtherm XP Cardioplegia Delivery System Uncoated Profile 3D Annuloplasty Ring EOPA Instant Detacher Axium Detachable Coil System MYOtherm CV-SH Cannulae, Fem Arterial 1-Piece, Bio-Medicus CV-SH Cannulae, Femoral Venous 1-Piece, BioMedicus Cement, Bone MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT BIOPUMP (VARIOUS MODELS) KYPHON ELEMENT" Inflatable Bone Tamp Launcher Guide Catheters Bio-probe Hancock II ULTRA Supra-X Aortic Sizers TriAd sizers Contour 3D sizers Mosaic Ultra Supra-X Aortic Sizers CG Future Sizers Hancock II Aortic and Mitral Obturators Simulus Sizers Avalus™ Sizers Open Pivot sizers Profile 3D Ring Sizers Mosaic Aortic and Mitral Obturators Freestyle Obturators Duran Ancore Sizers Mosaic Neo Endurant II AUI Stent Graft System Endurant Stent Graft System Endurant IIs Stent Graft System Endurant II Stent Graft System Talent Occluder with Occluder Delivery System Intersept ECMO Minimax Affinity Rist™ 079 Radial Access Guide Catheter Concerto Detachable Coil System 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 Affinity CP Centrifugal Blood Pump w/ Carmeda Bioactive Surf Ring, Annuloplasty - Contour 3D Ring Admiral Xtreme PTA Balloon Dilatation Catheter Admiral Xtreme PTA Balloon Dilatation Catheter (Long Balloon) DLP Cannula Affinity Sprinter Legend Rapid Exchange Balloon Dilatation Catheter 6F Sherpa NX Balanced7F Sherpa NX Balanced Admiral Xtreme PTA Balloon Dilatation Catheter Admiral Xtreme Cannula Biotherm Myotherm Affinity CP Centrifugal Bloop Pump w/ Balance Biosurface Axium Detachable Coil System DLP Air Aspirating Needle MYOtherm XP™ Cardioplegia Delivery System with Cortiva™ BioActive Surface Amphirion Deep 014" OTW PTA Balloon Catheter (Long Balloon) Amphirion Deep 014” OTW PTA Balloon Catheter Amphirion Deep PTA Catheter Bio-Medicus Life Support Catheter and Introducer Cannula Kyphon Inflation Syringe Avalus™ bioprosthesis General Instrument PASS LP Spinal System CSF-VENTRICULAR CATHETER, STANDARD MC2 Multistage DLP Rapid Prime Set, 14 Tissue Approximating Forceps FORCEPS (MANUAL INSTRU MULTIPLE FORCEPS Posterior Annuloplasty Band Cannulae, Femoral, Insertion Kits Marksman Catheter Axium Prime Detachable Coil System (FitzRoy) Rist 071 Radial Access Guide Catheter Rist Radial Access Selective Catheter Rist 079 Radial Access Guide Catheter DLP Suction Tube DLP Suction Tube, 6 1/2, Frazier Tip, 6 Fr. Adapter Mo.Ma Ultra Proximal Cerebral Protection Device

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2008-03-14
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2019-10-17
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2008-03-14
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2024-08-20
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-14
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2011-06-17
NPT Aortic Valve, Prosthesis, Percutaneously Delivered Unknown Class 3 N/A 2014-01-17
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2020-07-20
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2018-04-12
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2014-05-27
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2014-05-27
KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Cardiovascular Class 2 870.4360 2008-03-14
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2014-02-03
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2014-02-03
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
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 2018-07-01
HXG Tamp Orthopedic Class 1 888.4540 2010-11-18
HRX Arthroscope Orthopedic Class 2 888.1100 2010-11-18
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-14
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2018-07-18
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2020-07-14
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2006-07-06
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2018-04-25
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2021-03-03
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2021-03-03
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2021-03-03
DTF Tools, Pacemaker Service Cardiovascular Class 1 870.3730 2008-04-09
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2011-06-17
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2013-03-17
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-14
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 1995-08-10
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2020-11-19
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 1992-12-22
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 1992-12-22
MJG Device, Percutaneous, Biopsy General, Plastic Surgery Class 1 878.4800 2008-02-25
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2020-07-14
HCA Catheter, Ventricular Neurology Class 2 882.4100 2020-07-14
NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown Class f N/A 2021-04-01
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2013-02-11
DTN Reservoir, Blood, Cardiopulmonary Bypass Cardiovascular Class 2 870.4400 2015-06-05
DTP Defoamer, Cardiopulmonary Bypass Cardiovascular Class 2 870.4230 2015-06-05
MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown Class 3 N/A 2011-04-12
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-14
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 1992-12-22
DTN Reservoir, Blood, Cardiopulmonary Bypass Cardiovascular Class 2 870.4400 2008-03-14
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2015-04-24
LPB Cardiac Ablation Percutaneous Catheter Unknown Class 3 N/A 2013-03-28
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-14
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2012-10-09
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
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2013-02-19
HXG Tamp Orthopedic Class 1 888.4540 2013-02-19
HRX Arthroscope Orthopedic Class 2 888.1100 2013-02-19
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2008-09-15
NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown Class f N/A 2015-01-29
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2008-03-14
DTR Heat-Exchanger, Cardiopulmonary Bypass Cardiovascular Class 2 870.4240 2024-11-22
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2024-11-22
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-14
DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line Cardiovascular Class 2 870.4260 2026-01-20
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2014-08-18
CAC Apparatus, Autotransfusion Anesthesiology Class 2 868.5830 2008-03-14
QHW Single Lumen Ecmo Cannula Cardiovascular Class 2 870.4100 2025-02-14
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2025-02-14
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 2008-03-25
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
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 1992-12-02
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2011-04-11
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2011-04-11
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
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2019-04-08
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2019-10-24
CAC Apparatus, Autotransfusion Anesthesiology Class 2 868.5830 2008-03-14
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2008-03-25
DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line Cardiovascular Class 2 870.4260 2008-03-14
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2011-06-17
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2019-06-24
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2008-09-15
DWE Tubing, Pump, Cardiopulmonary Bypass Cardiovascular Class 2 870.4390 2008-03-14
CAC Apparatus, Autotransfusion Anesthesiology Class 2 868.5830 2010-05-13
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2020-07-14
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2011-06-17
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
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2014-01-28
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2008-03-14
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-14
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 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 2016-01-27
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2011-06-17
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2007-12-27
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-14
DTS Sucker, Cardiotomy Return, Cardiopulmonary Bypass Cardiovascular Class 2 870.4420 2017-10-05
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2008-01-16
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2011-06-17
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2013-02-11
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2013-02-11
KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Cardiovascular Class 2 870.4360 2013-11-26
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2011-06-17
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 2017-11-15
DRA Catheter, Steerable Cardiovascular Class 2 870.1280 2008-03-14
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-14
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2012-10-09
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 1995-04-14
PCB External Cerebrospinal Fluid (Csf) Diversion Neurology Class 2 882.5560 2014-11-30
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2015-04-03
OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown Class 3 N/A 2013-03-28
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2007-12-28
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2007-12-28
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2012-10-11
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-14
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2015-04-07
QNR Blood Pump For Ecmo, Long-Term (> 6 Hours) Use Cardiovascular Class 2 870.4100 2024-09-13
BYS Oxygenator, Long Term Support Greater Than 6 Hours Cardiovascular Class 2 870.4100 2024-09-13
QJZ Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure Cardiovascular Class 2 870.4100 2024-09-13
QWF Tubing, Long Term Support Greater Than 6 Hours Cardiovascular Class 2 870.4100 2024-09-13
DTR Heat-Exchanger, Cardiopulmonary Bypass Cardiovascular Class 2 870.4240 2017-03-03
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2008-06-18
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-14
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2008-11-12
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 2014-11-20
HRX Arthroscope Orthopedic Class 2 888.1100 2008-02-04
KIH Dispenser, Cement Orthopedic Class 1 888.4200 2008-02-04
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2008-02-04
HXG Tamp Orthopedic Class 1 888.4540 2008-02-04
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2015-04-14
KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Cardiovascular Class 2 870.4360 2000-06-02
HRX Arthroscope Orthopedic Class 2 888.1100 2015-08-07
HXG Tamp Orthopedic Class 1 888.4540 2015-08-07
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2023-07-03
DPT Probe, Blood-Flow, Extravascular Cardiovascular Class 2 870.2120 2008-03-14
DTI Sizer, Heart-Valve, Prosthesis Cardiovascular Class 1 870.3945 1992-07-30
MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown Class 3 N/A 2010-12-22
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2008-03-14
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2020-09-09
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2009-03-13
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2023-07-21
KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Cardiovascular Class 2 870.4360 2011-09-13
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2012-04-12
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2012-10-09
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2012-10-09
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-14
DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line Cardiovascular Class 2 870.4260 2008-03-14
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2026-01-20
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2023-09-27
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2010-08-11
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
KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Cardiovascular Class 2 870.4360 2011-09-13
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2015-08-13
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2015-08-13
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 2017-03-13
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2010-05-26
QHW Single Lumen Ecmo Cannula Cardiovascular Class 2 870.4100 2022-02-25
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-14
HRX Arthroscope Orthopedic Class 2 888.1100 2011-03-24
HXG Tamp Orthopedic Class 1 888.4540 2011-03-24
LWR Heart-Valve, Non-Allograft Tissue Unknown Class 3 N/A 2017-08-04
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2006-06-29
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2008-09-15
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-14
KPE Container, I.V. General Hospital Class 2 880.5025 2008-03-14
HTD Forceps General, Plastic Surgery Class 1 878.4800 2006-06-29
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2012-11-26
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 2018-07-01
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2009-10-29
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2017-01-24
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2017-01-24
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2025-02-26
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2025-02-26
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-02-26
DTS Sucker, Cardiotomy Return, Cardiopulmonary Bypass Cardiovascular Class 2 870.4420 2008-03-14
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2008-03-14
DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass Cardiovascular Class 2 870.4330 2015-04-24
NTE Temporary Carotid Catheter For Embolic Capture Cardiovascular Class 2 870.1250 2010-08-16

Official Correspondent

No official correspondent registered.

US Agent Details

Celia Encinas Business: Medtronic Email: celia.encinas@medtronic.com Phone: (949) 7983913

Related Public Records

Same Entity

Medtronic, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3007042319 HeartWare, Inc. Miami Lakes, FL, US
3004497303 MEDTRONIC MEXICO EG EMPALME Sonora, MX
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
K043580 Chestnut Medical Technologies, Inc. ALLIGATOR RETRIEVAL DEVICE (ARD) 2005-03-24
K982883 Medtronics Interventional Vascular MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER 1998-09-04
K132420 Reflow Medical WINGMAN EXTENDABLE TIP SUPPORT CATHETER 2013-09-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2010 Penumbra Inc. 2
Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014 Cordis Corporation 2
Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04 Bard Peripheral Vascular 2
Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Z-0010-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

Similar Registrations

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617601. Last updated year: 2026. Please use registration number 9617601 when referencing this establishment in official correspondence.
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