BEUDAMED
    FDA Registration Active 🇺🇸 United States

    RESPICARDIA, INC.

    Reg #: 3009144177 · FEI: 3009144177 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    3
    Establishment Types
    4
    Classifications
    5

    Registration Details

    Registration Name
    RESPICARDIA, INC.
    Registration Number
    3009144177
    FEI Number
    3009144177
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    12400 Whitewater Dr Ste 150
    City
    Minnetonka
    State
    MN
    ZIP
    55343
    Country
    US

    Regulatory Submissions

    510(k) Number
    K130378
    PMA Number
    P160039

    Owner / Operator

    Firm Name
    Respicardia, Inc.
    Operator Number
    10046158
    Address
    12400 Whitewater Drive, Suite 150
    City
    Minnetonka
    State
    MN
    Postal Code
    55343
    Country
    US
    Correspondent
    Kevin Bentley

    Products

    Device Name Product Code
    Catheter, Intravascular, Diagnostic DQO
    Catheter, Percutaneous DQY
    Implanted Phrenic Nerve Stimulator For Central Sleep Apnea PSR
    Pulse Generator, Permanent, Implantable NVZ
    Introducer, Catheter DYB

    Proprietary Names

    respiguide™ Delivery System remede® System VANES Delivery System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Manufacture Device in the United States for Export Only Complaint File Establishment per 21 CFR 820.198