BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Peregrine System(TM) Infusion Catheter

    Reg #: 3010334444 · FEI: 3010334444 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ABLATIVE SOLUTIONS, INC.
    Registration Number
    3010334444
    FEI Number
    3010334444
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    301 Edgewater Place, Suite 100
    City
    Wakefield
    State
    MA
    ZIP
    01880
    Country
    US

    Regulatory Submissions

    510(k) Number
    K231279

    Owner / Operator

    Firm Name
    Ablative Solutions, Inc.
    Operator Number
    10044459
    Address
    301 Edgewater Place, Suite 100
    City
    Wakefield
    State
    MA
    Postal Code
    01880
    Country
    US
    Correspondent
    Kristine Canavan

    Products

    Device Name Product Code
    Catheter, Continuous Flush KRA

    Proprietary Names

    Peregrine System(TM) Infusion Catheter

    Establishment Types

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