BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Medtronic Neurosurgery

    Reg #: 3015531529 · FEI: 3015531529 · Expires 2026
    View on FDA
    Products
    21
    Proprietary Names
    89
    Establishment Types
    1
    Classifications
    21

    Registration Details

    Registration Name
    Medtronic Neurosurgery
    Registration Number
    3015531529
    FEI Number
    3015531529
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4620 North Beach Street
    City
    Fort Worth
    State
    TX
    ZIP
    76137
    Country
    US

    Regulatory Submissions

    510(k) Number
    K803257

    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
    Shunt, Central Nervous System And Components JXG
    Drills, Burrs, Trephines & Accessories (Manual) HBG
    Device, Monitoring, Intracranial Pressure GWM
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC
    Port & Catheter, Implanted, Subcutaneous, Intraventricular LKG
    External Cerebrospinal Fluid (Csf) Diversion PCB
    Mesh, Surgical FTM
    Plate, Bone JEY
    Catheter, Percutaneous, Intraspinal, Short Term MAJ
    Endoscope, Neurological GWG
    Instrument, Shunt System Implantation GYK
    Light Source, Endoscope, Xenon Arc GCT
    Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET
    Mesh, Surgical, Metal EZX
    Cover, Burr Hole GXR
    Plate, Cranioplasty, Preformed, Non-Alterable GXN
    Catheter, Ventricular HCA
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Clip, Scalp HBO
    Port & Catheter, Implanted, Subcutaneous, Intravascular LJT

    Proprietary Names

    CSF-FLOW CONTROL VALVE PS MEDICAL CRANIAL HAND DRILL P-S MED. LUMBO PERITONEAL & VENTRIC PS MEDICAL CSF-FLOW CONTROL VALVE BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM PS MEDICAL CSF-ACCESS DEVICE Timesh System INTRACRANIAL PRESSURING MONITORING SYSTEM MACROPORE PROTECTIVE SHEET MEDTRONIC PS MEDICAL STRATA TYPE VA Becker External Drainage and Monitoring System P-S MEDICAL VENTRICULAR ACCESS PORT Duet External Drainage and Monitoring System (EDMS) TIMESH CRANIAL FIXATION SYSTEM TIMESH TITANIUM MINI-SOFTPLATE/SCRE MEDTRONIC PS MEDICAL POLYURETHANE SHUNT IPI ALGO-LINE CATHETER PS MEDICAL CATHETER PLACEMENT KIT RIVULET VENTRICULAR AND SNAP SHUNT SUBDURAL EVACUATING PORT SYSTEM Medtronic External Drainage and Monitoring System (EDMS) Duet EDMS STRATA NSC BURR HOLE VALVE STRATA NSC BURR HOLE SHUNT ASSEMBLY MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE BECKER EXTERNAL DRAINAGE/MONITOR SYSTEM LUMBAR CATHETER ARES Antibiotic Impregnated Catheters StrataMR™ II Valves and Shunts TIMESH TITANIUM MINI-SOFTPLATE & MICRO-SOFT PLATE/SCREW SYSTEM MEDTRONIC PS MEDICAL MURPHYSCOPE PS MEDICAL STRATA II VALVE MEDTRONIC M2 MAGNET ADJUST. TOOL PS MEDICAL DISPOSABLE SUBCUTANEOUS CATHETER PASSER PS MEDICAL DISPOSABLE SUB MEDTRONIC PS MEDICAL EXTERNAL DRAINAGE AND MONITORING VENTRICULAR CATHETER P-S MEDICAL CSF ACCESS DEV 15MM/25M Strata NSC Lumboperitoneal Shunt System Strata NSC LP Valve Strata NSC LP Shunt Strata NSC Lumboperitoneal Valve SERIES 5000 ENDOSCOPE CON ENDOSCOPE CONSOLE TIMESH SYSTEM PS MEDICAL CSF SIPHON CONTROL DEVIC SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT SEPS-CA SEPS-CAL SEPS-CAND Strata NSC LP Shunt System PS MEDICAL DELTA BURR HOLE VALVE MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM CSF-VENTRICULAR CATHETER, STANDARD Exacta External Drainage and Monitoring System (EDMS) PS MEDICAL BUTTON VALVE PS MEDICAL VENTRICULOSTOMY KIT PS MEDICAL CSF-ON/OFF FLUSHING RESE MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES CSF CARDIAC PERITONEAL CATHETER MEDTRONIC PS MEDICAL EXACTA DRAINAGE SYSTEM POLE CLAMP MEDTRONIC PS MEDICAL EXACTA DRAINAGE SYSTEM CSF-VENTRICULOSTOMY RESERVOIR PS MEDICAL DELTA CSF-FLOW CONTROL VALVE BIPOLAR PENCIL P-S CSF-VENTRICULAR CATHETER, FLANG CSF-CARDIAC/PERITONEAL CATHETER StrataMR Valves and Shunts NEURO CHANNEL ENDOSCOPE TISMESH SYSTEM MEDTRONIC CLIP GUN KIT MEDTRONIC STRATAVARIUS MACROPORE FX, PS, NS, LP MACROPORE-PX PEDIATRIC SYSTEM PS MEDICAL BIOGLIDE CSF MEDTRONIC PS MEDICAL INTRODUCER SHE CSF-FLOW CONTROL VALVE, ULTRA SMALL MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES CLIP GUN WITH RANEY TYPE SCALP CLIP PS MEDICAL CSF FLOW CONTROL VALVE INNERVISION CATHETER PS MEDICAL CSF-LUMBOPERITONEAL SHU StrataMR Valves and Shunts (Guider Tool) NEUROPEN STRATA BURR HOLE VALVE STRATA BURR HOLE SHUNT ASSEMBLY DUET External Drainage And Monitoring System Medtronic DUET External Drainage And Monitoring System DUET DUET EDMS SMALL LUMEN PERITONEAL CATHETER

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility