BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Finesse Injectable PTA Balloon Dilatation Catheter

    Reg #: 3027395815 · FEI: 3027395815 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    SUMMA THERAPEUTICS, LLC
    Registration Number
    3027395815
    FEI Number
    3027395815
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    119 Braintree St Ste 508
    City
    Allston
    State
    MA
    ZIP
    02134
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241740

    Owner / Operator

    Firm Name
    Summa Therapeutics, LLC
    Operator Number
    10088115
    Address
    119 Braintree St Ste 508
    City
    Boston
    State
    MA
    Postal Code
    02134
    Country
    US
    Correspondent
    Timothy Murphy

    Products

    Device Name Product Code
    Catheter, Angioplasty, Peripheral, Transluminal LIT
    Catheter, Continuous Flush KRA

    Proprietary Names

    Finesse Injectable PTA Balloon Dilatation Catheter

    Establishment Types

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