BEUDAMED
    FDA Registration Active 🇺🇸 United States

    exGraft

    Reg #: 3013718163 · FEI: 3013718163 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PECA LABS, INC.
    Registration Number
    3013718163
    FEI Number
    3013718163
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4424 Penn Avenue, Suite 201
    City
    Pittsburgh
    State
    PA
    ZIP
    15224
    Country
    US

    Regulatory Submissions

    510(k) Number
    K183613

    Owner / Operator

    Firm Name
    PECA Labs, Inc.
    Operator Number
    10055472
    Address
    4424 Penn Avenue, Suite 201
    City
    Pittsburgh
    State
    PA
    Postal Code
    15224
    Country
    US
    Correspondent
    Doug Bernstein

    Products

    Device Name Product Code
    Prosthesis, Vascular Graft, Of 6mm And Greater Diameter DSY

    Proprietary Names

    exGraft

    Establishment Types

    Manufacture Medical Device