BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EBR SYSTEMS INC.

    Reg #: 3013596742 · FEI: 3013596742 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    7
    Establishment Types
    3
    Classifications
    7

    Registration Details

    Registration Name
    EBR SYSTEMS INC.
    Registration Number
    3013596742
    FEI Number
    3013596742
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    480 Oakmead Pkwy
    City
    Sunnyvale
    State
    CA
    ZIP
    94085
    Country
    US

    Regulatory Submissions

    510(k) Number
    K053389
    PMA Number
    P240028

    Owner / Operator

    Firm Name
    EBR Systems Inc.
    Operator Number
    10092727
    Address
    480 Oakmead Parkway
    City
    Sunnyvale
    State
    CA
    Postal Code
    94085
    Country
    US
    Correspondent
    Pharoah Garma

    Products

    Device Name Product Code
    Wrap, Sterilization FRG
    Sterilizer, Steam FLE
    Dilator, Cervical, Fixed Size HDQ
    Retractor GAD
    Cardiovascular Delivery Catheter System Positioning And Stabilization Device QWA
    Forceps HTD
    Leadless Cardiac Resynchronization Therapy (Crt) SEG

    Proprietary Names

    Sterilization wrap Bottom Container Steam Sterilization Top Container Uterine Dilator Retractor Coupler Surgical Forceps WiSE (Wireless Stimulation of the Endocardium Technology) CRT System

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198