BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Medtronic, Inc.

    Reg #: 2183870 · FEI: 2183870 · Expires 2026
    View on FDA
    Products
    21
    Proprietary Names
    98
    Establishment Types
    3
    Classifications
    21

    Registration Details

    Registration Name
    Medtronic, Inc.
    Registration Number
    2183870
    FEI Number
    2183870
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4600 Nathan Lane North
    City
    Plymouth
    State
    MN
    ZIP
    55442
    Country
    US

    Regulatory Submissions

    510(k) Number
    K120881
    PMA Number
    P200026

    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
    Wire, Guide, Catheter DQX
    Catheter, Angioplasty, Peripheral, Transluminal LIT
    Catheter, Percutaneous DQY
    Catheter, Continuous Flush KRA
    Aspiration Thrombectomy Catheter QEZ
    Catheter, Peripheral, Atherectomy MCW
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Device, Vascular, For Promoting Embolization KRD
    Stent, Iliac Vein QAN
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Stent, Superficial Femoral Artery NIP
    Catheter, Embolectomy DXE
    Device, Percutaneous Retrieval MMX
    Temporary Carotid Catheter For Embolic Capture NTE
    Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection NFA
    Stent, Iliac NIO
    Stent, Carotid NIM
    Introducer, Catheter DYB
    Agent, Occluding, Vascular, Permanent PJQ
    Catheter For Crossing Total Occlusions PDU
    Flowmeter, Blood, Cardiovascular DPW

    Proprietary Names

    Enteer (Mantaray) Guidewire M-600,M6001,M6002,M-6003,M-6004,M-6005 Fortrex HP PTA Balloon Catheter NanoCross Elite 14 Over The Wire PTA Balloon Dilatation Catheter NanoCross Elite™ PTA Catheter TrailBlazer™ Angled Support Catheter Rinspirator Enteer (Mantaray) Percutaneous Catheter M-4000 and M-4001 HawkOne Directional Atherectomy System HawkOne 7Fr ClosureFast™ Endovenous Radiofrequency Ablation Catheter PowerCross 18 OTW Balloon Cable Sets MVP Detachment System Micro Vascular Plug System Detachment System (MVP) Micro Vascular Plug System (MVP) Cable Sets MVP SilverHawk for Surgical Use TurboHawk Supper Cutter LS-E, LX-E ClosureFAST™ Endovenous Radiofrequency Ablation (RFA) Catheter Amphirion Deep 014" OTW PTA Balloon Catheter Amphirion Deep PTA Catheter Amphirion Deep 014" OTW PTA Balloon Catheter (Balloon Extension) Amphirion Deep 014” OTW PTA Balloon Catheter Wholey Guide Wire System Wholey Wire Abre™ Venous Self-expanding Stent System Protege GPS Self-Expanding Peripheral Stent System Protege EverFlex PRP35 Orion Micro Catheter ClosureRFS™ Endovenous Radiofrequency Stylet EverCross™ PTA Catheter SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM Protege EverFlex self-expanding biliary stent system Everflex Self-Expanding Peripheral Stent With Entrust Delivery System Protege EverFlex Self-Expanding Peripheral Stent System EverFlex Self-Expanding Peripheral Stent System Protege EverFlex Amplatz™ Goose Neck Snare Kit PRIMUS GPS Biliary Stent (Visi-Pro) Amplatz Goose Neck Microsnare AqWire Hydrophilic Guidewire TurboHawk Peripheral Plaque Excision System BTK (models SS-C, SS-CL, SX-C) Regulation Name: Intraluminal Artery Strippe Mantaray Guidewire Enteer™ Guidewire SilverHawk Peripheral Plaque Excisi VNUS Radiofrequency Generator, Model RFG2 ClosureRFG Radiofrequency Generator (RFG2) RFG2 Next Gen RFG2 ClosureRFG™ Radiofrequency Generator ClosureFAST™ Radiofrequency Ablation Catheter SilverHawk Peripheral Plaque Excision System SpiderFX Embolic Protection Device Peripheral Indication Admiral Xtreme PTA Balloon Dilatation Catheter Admiral Xtreme PTA Balloon Dilatation Catheter (Long Balloon) Nitrex Guidewire IntraStent Mega/Max LD Stent, Bilia Chocolate PTA Balloon Catheter NanoCross 14 OTW PTA SpiderFX Embolic Protection Device TrailBlazer™ Support Catheter PROTEGE GPS AND PROTEGE PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS The Big Easy Y-Adapter models SS-C, SS-CL, SX-C TurboHawk Peripheral Plaque Excision System models THS-LS-C, THS-LX-C VenaSeal™ Closure System Pacific Plus PTA Catheter "Micro Vascular Plug System (MVP) MVP Cable Sets MVP Detachment System " Amplatz Goose Neck Snare Kit/Catheter Peripheral System Percutaneous Catheter Mantaray Catheters Mantaray Guidewires BigBoss Catheters Enteer Re-entry Catheter, Enteer GuideWire, Viance Crossing Catheter RapidCross PTA Rapid Exchange Balloon Dilatation Catheter RapidCross RX PTA Catheter TurboHawk Plus Directional Atherectomy System BridgePoint Medical Peripheral System: Mantaray™ Guidewires Mantaray™ Guidewires Enteer Guidewire Protege EverFlex Self-Expanding Biliary Stent System Protege EverFlex Biliary 6-8mm Admiral Xtreme HawkOne™ Directional Atherectomy System Intraluminal artery stripper HawkOne 6Fr Admiral Xtreme PTA Balloon Catheter Protege GPS self-expanding peripheral stent system Amphirion Deep 014" OTW PTA Balloon Catheter (Long Balloon) FlowMet-D HawkOne™ Directional Atherectomy System IntraStent LD DoubleStrut Biliary Stent VenaSeal Closure System Mo.Ma Ultra Proximal Cerebral Protection Device IntraStent Double Strut Iliac Visi-Pro Stent and Delivery System Amphirion Deep 014" OTW PTA Balloon Catheter (Shaft Extension) BabyWire

    Establishment Types

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