BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Reflow Medical

    Reg #: 3027058844 · FEI: 3027058844 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    14
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    Reflow Medical
    Registration Number
    3027058844
    FEI Number
    3027058844
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    20532 Crescent Bay Dr. Suite 100
    City
    Lake Forest
    State
    CA
    ZIP
    92630
    Country
    US

    Regulatory Submissions

    510(k) Number
    K201811

    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

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

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)