BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HeartStitch, INC.

    Reg #: 3009142291 · FEI: 3009142291 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    10
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    HeartStitch, INC.
    Registration Number
    3009142291
    FEI Number
    3009142291
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    17074 Newhope St
    City
    Fountain Valley
    State
    CA
    ZIP
    92708
    Country
    US

    Regulatory Submissions

    510(k) Number
    K980128

    Owner / Operator

    Firm Name
    HeartStitch, Inc.
    Operator Number
    10036047
    Address
    17074 Newhope Str.
    City
    Fountain Valley
    State
    CA
    Postal Code
    92708
    Country
    US
    Correspondent
    Anthony Nobles

    Products

    Device Name Product Code
    Clamp, Vascular DXC
    Suture, Nonabsorbable, Synthetic, Polypropylene GAW
    Instrument, Ligature Passing And Knot Tying HCF

    Proprietary Names

    Cardio Inverter Inverter HeartStitch EL NobleStitch TA HeartStitch MR HeartStitch TA NobleStitch EL NobleStitch MR SRM-Stitch¿ 8F KwiKnot

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)