BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Route 92 Medical, Head Quarters

    Reg #: 3016522967 · FEI: 3016522967 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    6
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    Route 92 Medical, Head Quarters
    Registration Number
    3016522967
    FEI Number
    3016522967
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    155 Bovet Road, Suite 100
    City
    San Mateo
    State
    CA
    ZIP
    94402
    Country
    US

    Regulatory Submissions

    510(k) Number
    K240529

    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, Percutaneous, Neurovasculature QJP
    Catheter, Percutaneous DQY
    Catheter, Thrombus Retriever NRY

    Proprietary Names

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

    Establishment Types

    Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device