BEUDAMED
    FDA Registration Active 🇺🇸 United States

    REFLOW MEDICAL, INC

    Reg #: 3008789872 · FEI: 3008789872 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    13
    Establishment Types
    4
    Classifications
    3

    Registration Details

    Registration Name
    REFLOW MEDICAL, INC
    Registration Number
    3008789872
    FEI Number
    3008789872
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    208 Avenida Fabricante, Suite 100
    City
    San Clemente
    State
    CA
    ZIP
    92672
    Country
    US

    Regulatory Submissions

    510(k) Number
    K193012

    Owner / Operator

    Firm Name
    Reflow Medical
    Operator Number
    10034685
    Address
    208 Avenida Fabricante, Suite 100
    City
    San Clemente
    State
    CA
    Postal Code
    92672
    Country
    US
    Correspondent
    Angela Lamprey

    Products

    Device Name Product Code
    Catheter, Percutaneous DQY
    Peripheral Temporary And Retrievable Stent System SEU
    Catheter For Crossing Total Occlusions PDU

    Proprietary Names

    Spex Support Catheters coraCross speX Catheter Cora Microcatheters Wingman 35 Crossing Catheter Wingman 14 Crossing Catheter Wingman 14C Crossing Catheter Wingman Coronary Crossing Catheter Spur Peripheral Retrievable Stent System Wingman Crossing Catheters Spex LP Support Catheters coraForce coraFlex

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility