BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MicroVention, Inc.

    Reg #: 3013556777 · FEI: 3013556777 · Expires 2026
    View on FDA
    Products
    23
    Proprietary Names
    79
    Establishment Types
    4
    Classifications
    23

    Registration Details

    Registration Name
    MicroVention, Inc.
    Registration Number
    3013556777
    FEI Number
    3013556777
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    35 Enterprise
    City
    Aliso Viejo
    State
    CA
    ZIP
    92656
    Country
    US

    Regulatory Submissions

    510(k) Number
    K093397
    PMA Number
    P170013

    Owner / Operator

    Firm Name
    MicroVention Inc.
    Operator Number
    10033879
    Address
    35 Enterprise
    City
    Aliso Viejo
    State
    CA
    Postal Code
    92656
    Country
    US
    Correspondent
    Scafford Serron

    Products

    Device Name Product Code
    Wire, Guide, Catheter DQX
    Guide, Wire, Catheter, Neurovasculature MOF
    Catheter, Percutaneous DQY
    Device, Neurovascular Embolization HCG
    Device, Vascular, For Promoting Embolization KRD
    Temporary Carotid Catheter For Embolic Capture NTE
    Catheter, Intravascular, Diagnostic DQO
    Tube, Aspirating, Flexible, Connecting BYY
    Intracranial Coil-Assist Stent QCA
    Catheter, Thrombus Retriever NRY
    Catheter, Percutaneous, Neurovasculature QJP
    Apparatus, Suction, Ward Use, Portable, Ac-Powered JCX
    Pump, Portable, Aspiration (Manual Or Powered) BTA
    Catheter, Intravascular Occluding, Temporary MJN
    Stent, Carotid NIM
    Catheter, Continuous Flush KRA
    Intrasaccular Flow Disruption Device OPR
    Intracranial Aneurysm Flow Diverter OUT
    Dural Arteriovenous Fistula Liquid Embolic SGF
    Syringe, Piston FMF
    Agents, Embolic, For Treatment Of Uterine Fibroids NAJ
    Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia NOY
    Drug-Eluting Peripheral Transluminal Angioplasty Catheter ONU

    Proprietary Names

    Traxcess 14EX Guidewire Traxcess 7 Mini Guidewire Headway 17 Advanced Soft Wedge HydroFrame 18 & 10 (Line Ext) Azur Pure Peripheral Coil System, Pushable 35 EmPro Embolic Protection System Nanoparasol Embolic Protection System Headway Duo Microcatheter MCS & HES Coils (V-Trak Advanced) AZUR PURE Peripheral Coil System, Pushable 18 SOFIA Distal Access Catheter AZUR CX Coil System - Detachable 18 Headway 17 Adv MicroPlex Coil System, HydroCoil Embolic System MicroVention Tubing Kit LifePearl VFC (Line Ext) LVIS, LVIS Jr., LVIS EVO Headway 27 Microcatheter ERIC™ Traxcess 14 Guidewire SOFIA 88 Catheter HydroFrame 10 SOFIA EX V-Trak MCS HES 12V V-Grip Detachment Controller Scepter Mini Occlusion Balloon Catheter Cosmos 18 SOFIA Catheter AZUR Detachable 18 LE MV Flow Aspiration Pump and MV Flow Canister Cosmos & HydroFrame 2 & 2.5 Headway 27 V-Trak HydroSoft Cosmos 10 (Line Ext) Scepter C & XC AZUR HydroPack HyperSoft 3D SOFIA EX Intracranial Support Catheter HydroSoft Cosmos 10 Traxcess 14 SELECT Guidewire CASPER Carotid Stent System Roadsaver Carotid Stent System VIA 17, 21, 27, 33 AZUR Vascular Plug AZUR CX Detachable 18 Peripheral Coil System Wedge XL Delivery Catheter Precipitating Hydrophobic Injectable Liquid (PHIL Liquid Embolic System) BOBBY Balloon Guide Catheter HydroFill (Formerly HydroSoft Plus) (Line Ext) AZUR Peripheral Coil System - Detachable 35 Headway 21 Traxcess Docking Wire Woven EndoBridge (WEB) Aneurysm Embolization System WDC-2 WEB Detachment Controller FRED, FRED Jr., FRED X Hypersoft 3D AZUR Pushable 18 Modification Azur Peripheral Coil - Detachable 35 Framing ISAAC Neurovascular Navigation Catheter AZUR Detachable 18 Chaperon VFC HydroFill (Formerly HydroSoft Plus) AZUR Peripheral Pushable PG Pro Microcatheter MicroVention Syringe Kit HydroPearl Microsphere 12V AZUR Detachment Controller Azur Detachable 35 AZUR Detachable Controller AZUR CX Peripheral Coil System- Detachable 35 Kanshas SOFIA Plus Aspiration with Tubing Kit 9V V-Grip Detachment Controller AZUR Pushable 18 & 35 LE HydroFill Filar Modification

    Establishment Types

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