BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Serranator PTA Serration Balloon Catheter

    Reg #: 3014598164 · FEI: 3014598164 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    CAGENT VASCULAR
    Registration Number
    3014598164
    FEI Number
    3014598164
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    150 Strafford Avenue, #315
    City
    Wayne
    State
    PA
    ZIP
    19087
    Country
    US

    Regulatory Submissions

    510(k) Number
    K193181

    Owner / Operator

    Firm Name
    Cagent Vascular
    Operator Number
    10060763
    Address
    150 Strafford Avenue, #315
    City
    Wayne
    State
    PA
    Postal Code
    19087
    Country
    US
    Correspondent
    Peter Johansson

    Products

    Device Name Product Code
    Catheter, Percutaneous, Cutting/Scoring PNO

    Proprietary Names

    Serranator PTA Serration Balloon Catheter

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198