BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Route 92 Medical, West Jordan

    Reg #: 3030088112 · FEI: 3030088112 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    Route 92 Medical, West Jordan
    Registration Number
    3030088112
    FEI Number
    3030088112
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1375 W 8040 S
    City
    W Jordan
    State
    UT
    ZIP
    84088
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233329

    Owner / Operator

    Firm Name
    Route 92 Medical
    Operator Number
    10054934
    Address
    155 Bovet Road, Suite 100
    City
    San Mateo
    State
    CA
    Postal Code
    94402
    Country
    US
    Correspondent
    Matthew Fortson

    Products

    Device Name Product Code
    Catheter, Thrombus Retriever NRY
    Catheter, Percutaneous, Neurovasculature QJP
    Catheter, Percutaneous DQY

    Proprietary Names

    FreeClimb 54 Reperfusion Catheter with Tenzing 5 FreeClimb 54 Reperfusion System HiPoint reperfusion catheter with Tenzing FreeClimb 70 reperfusion catheter with Tenzing 7 Base Camp Sheath System 2 Berenstein 80cm Base Camp Sheath System 2 Berenstein 90cm

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device