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    Route 92 Medical, Inc.

    Manufacturer
    🇺🇸 United States·1 Basic UDI-DI·1 Device·1 Importer·DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, and DQS Medizinprodukte GmbH

    Tenzing 7

    Device
    EU MDR · Eu Md Class 3 ·Route 92 Medical, Inc.·On the market·4 countries

    Tenzing 7 Delivery Catheter

    Basic UDI-DI
    EU MDR · Eu Md Class 3 ·Route 92 Medical, Inc.·1 device

    HIPOINT 88

    FDA Adverse Event
    Death ·ROUTE 92 MEDICAL, INC.·Product code QJP·November 11, 2025

    HIPOINT 88 ACCESS SYSTEM (088 ACCESS SYSTEM)

    FDA Adverse Event
    Death ·ROUTE 92 MEDICAL, INC.·Product code QJP·September 27, 2023

    FULL LENGTH 070 REPERFUSION SYSTEM (FREECLIMB 70 REPERFUSION SYSTEM)

    FDA Adverse Event
    Malfunction ·ROUTE 92 MEDICAL, INC.·Product code NRY·September 27, 2023

    HIPOINT 88 ACCESS SYSTEM (088 ACCESS SYSTEM)

    FDA Adverse Event
    Injury ·ROUTE 92 MEDICAL, INC.·Product code QJP·January 12, 2024

    088 ACCESS SYSTEM (HIPOINT 88)

    FDA Adverse Event
    Injury ·ROUTE 92 MEDICAL, INC.·Product code QJP·February 24, 2023

    HIPOINT 88 ACCESS SYSTEM (088 ACCESS SYSTEM)

    FDA Adverse Event
    Injury ·ROUTE 92 MEDICAL, INC.·Product code QJP·December 5, 2023

    HIPOINT 88 ACCESS SYSTEM (088 ACCESS SYSTEM)

    FDA Adverse Event
    Injury ·ROUTE 92 MEDICAL, INC.·Product code QJP·January 12, 2024

    FREECLIMB 70 REPERFUSION SYSTEM

    FDA Adverse Event
    Injury ·ROUTE 92 MEDICAL, INC.·Product code NRY·March 20, 2024

    FREECLIMB 70 REPERFUSION SYSTEM

    FDA Adverse Event
    Death ·ROUTE 92 MEDICAL, INC.·Product code NRY·February 7, 2024

    FREECLIMB 70 REPERFUSION SYSTEM

    FDA Adverse Event
    Malfunction ·ROUTE 92 MEDICAL, INC.·Product code NRY·November 11, 2024

    FREECLIMB 70 REPERFUSION SYSTEM

    FDA Adverse Event
    Injury ·ROUTE 92 MEDICAL, INC.·Product code NRY·November 11, 2024

    070 ACCESS SYSTEM (HIPOINT 70)

    FDA Adverse Event
    Malfunction ·ROUTE 92 MEDICAL, INC.·Product code QJP·November 8, 2024

    FREECLIMB 54 REPERFUSION SYSTEM

    FDA Adverse Event
    Malfunction ·ROUTE 92 MEDICAL, INC.·Product code NRY·April 16, 2025

    BASE CAMP SHEATH SYSTEM

    FDA Adverse Event
    Malfunction ·ROUTE 92 MEDICAL, INC.·Product code DQY·April 16, 2025

    HIPOINT 88

    FDA Adverse Event
    Malfunction ·ROUTE 92 MEDICAL, INC.·Product code QJP·April 26, 2025

    FREECLIMB 70 REPERFUSION SYSTEM

    FDA Adverse Event
    Injury ·ROUTE 92 MEDICAL, INC.·Product code NRY·February 19, 2025

    088 ACCESS SYSTEM

    FDA Adverse Event
    Death ·ROUTE 92 MEDICAL, INC.·Product code QJP·December 15, 2022