BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BIOCARDIA, INC.

    Reg #: 3003610571 · FEI: 3003610571 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    BIOCARDIA, INC.
    Registration Number
    3003610571
    FEI Number
    3003610571
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    320 Soquel Way
    City
    Sunnyvale
    State
    CA
    ZIP
    94085
    Country
    US

    Regulatory Submissions

    510(k) Number
    K012749

    Owner / Operator

    Firm Name
    BioCardia
    Operator Number
    9038602
    Address
    320 Soquel Way
    City
    Sunnyvale
    State
    CA
    Postal Code
    94085
    Country
    US
    Correspondent
    Peter Altman

    Products

    Device Name Product Code
    Catheter, Intravascular, Diagnostic DQO
    Introducer, Catheter DYB
    Catheter, Percutaneous DQY

    Proprietary Names

    Morph Universal Deflectable Guide Catheter Morph DNA Steerable Sheath Avance Steerable Introducer Morph DNA Steerable Guide Catheter Morph Sheath Guide

    Establishment Types

    Manufacture Medical Device