BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PerfIC Cath Hydro-C

    Reg #: 3008772421 · FEI: 3008772421 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ADAPTA MEDICAL, INC.
    Registration Number
    3008772421
    FEI Number
    3008772421
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    142 Talamine Ct
    City
    Colorado Springs
    State
    CO
    ZIP
    80907
    Country
    US

    Regulatory Submissions

    510(k) Number
    K161445

    Owner / Operator

    Firm Name
    Adapta Medical, Inc
    Operator Number
    10033957
    Address
    142 Talamine Court
    City
    Colorado Springs
    State
    CO
    Postal Code
    80907
    Country
    US
    Correspondent
    Glen House

    Products

    Device Name Product Code
    Catheter, Straight EZD

    Proprietary Names

    PerfIC Cath Hydro-C mPower Cath Hydro-C PerfIC Cath Hydro-S PerfIC Cath Gel-S mPower Cath Hydro-S

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device