BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PECA LABS, INC.

    Reg #: 3013718163 · FEI: 3013718163 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    PECA LABS, INC.
    Registration Number
    3013718163
    FEI Number
    3013718163
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4424 Penn Avenue, Suite 201
    City
    Pittsburgh
    State
    PA
    ZIP
    15224
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180957

    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
    Prosthesis, Vascular Graft, Of Less Then 6mm Diameter DYF

    Proprietary Names

    exGraft Peripheral exGraft E20P exGraft exGraft ePTFE Vascular Graft exGraft and exGraft Carbon ePTFE Vascular Grafts

    Establishment Types

    Manufacture Device in the United States for Export Only Manufacture Medical Device