BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Verge Medical Inc.

    Reg #: 3008700817 · FEI: 3008700817 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    9
    Establishment Types
    3
    Classifications
    5

    Registration Details

    Registration Name
    Verge Medical Inc.
    Registration Number
    3008700817
    FEI Number
    3008700817
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    747 Camden Ave Ste A
    City
    Campbell
    State
    CA
    ZIP
    95008
    Country
    US

    Regulatory Submissions

    510(k) Number
    K152485

    Owner / Operator

    Firm Name
    Verge Medical Inc.
    Operator Number
    10034123
    Address
    747 Camden Ave, STE A
    City
    Campbell
    State
    CA
    Postal Code
    95008
    Country
    US

    Products

    Device Name Product Code
    Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX
    Catheter, Intravascular, Diagnostic DQO
    Peripheral Mechanical Thrombectomy With Aspiration QEW
    Catheter, Angioplasty, Peripheral, Transluminal LIT
    Catheter, Percutaneous DQY

    Proprietary Names

    Ostial Corporation/Verge Medical Inc./FLASH MINI Ostial System FLASH MINI Ostial System FLASH Ostial System Ostial Corporation/Verge Medical Inc./Flash Ostial System FLASH Flex™ Aorto-Ostial Angioplasty System RoVo Mechanical Thrombectomy System FLASH Ostial System OTW Ostial Corporation/Verge Medical Inc./FLASH Ostial System OTW Ostial Corporation/Verge Medical Inc./FLASH Ostial System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device