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510(k) Data Aggregation

    K Number
    K210635
    Device Name
    Route 92 Medical Full Length 088 Access System
    Manufacturer
    Route 92 Medical Inc.
    Date Cleared
    2021-07-27

    (146 days)

    Product Code
    QJP
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Route 92 Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Route 92 Medical Full Length 088 Access System is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system.
    Device Description
    The Route 92 Medical Full Length 088 Access System is comprised of a Support Catheter and a Delivery Catheter. The Support Catheter is a single-lumen, variable stiffness catheter. The Delivery Catheter is a hubbed, single-lumen variable stiffness catheters are hydrophilically coated. The Route 92 Medical Full Length 088 Access System is intended for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system. The devices are provided sterile and non-pyrogenic and are intended for single use only.
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    K Number
    K200121
    Device Name
    Route 92 Medical 088 Access System, 110 cm
    Manufacturer
    Route 92 Medical Inc.
    Date Cleared
    2020-04-18

    (88 days)

    Product Code
    QJP
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Route 92 Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Route 92 Medical 088 Access System, 110 cm, is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system.
    Device Description
    The Route 92 Medical 088 Access System, 110 cm, is comprised of a Support Catheter and a Delivery Catheter. The distal portion of the Support Catheter is a single-lumen, variable stiffness catheter. Like the predicate device, the proximal portion is a stainless-steel control wire. The Delivery Catheter is a hubbed, single-lumen variable stiffness catheter. Both catheters are hydrophilically coated. The Route 92 Medical Access System, 110 cm, is intended for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system. The devices are provided sterile and non-pyrogenic and are intended for single use only.
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    K Number
    K191717
    Device Name
    Route 92 Medical Sheath System
    Manufacturer
    Route 92 Medical Inc.
    Date Cleared
    2020-01-13

    (201 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Route 92 Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Route 92 Medical Sheath System is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
    Device Description
    The Route 92 Medical Sheath System is comprised of a Sheath, a Dilator, a Navigating Catheter, and an RHV (rotating hemostasis valve). The Sheath is a single-lumen, variable stiffness catheter with a radiopaque marker on the distal end. The inner lumen of the catheter is compatible with 8F or smaller catheters. The Dilator may be placed within the Sheath to facilitate percutaneous introduction of the Sheath into a femoral artery. The Dilator has a radiopaque marker at the distal tip. The Navigating Catheter is a single-lumen, variable stiffness catheter with a radiopaque marker at the distal tip. The Navigating Catheter is compatible with the Sheath and has a shaped distal end to facilitate placement. All of the catheters are coated with hydrophilic coating.
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    K Number
    K190431
    Device Name
    Route 92 Medical Delivery Catheter
    Manufacturer
    Route 92 Medical Inc.
    Date Cleared
    2019-03-21

    (27 days)

    Product Code
    DQY, DOY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Route 92 Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Route 92 Medical Delivery Catheter is indicated for use with compatible catheters in facilitating the insertion and guidance of catheters into a selected blood vessel in the neurovascular system.
    Device Description
    The modified Route 92 Medical Delivery Catheter is a single-lumen, variable stiffness, hydrophilically coated catheter with a flexible tapered tip. The tapered tip is delineated by two radiopaque markers. On the proximal end is a luer hub for guidewire introduction and fluid or contrast injection. The devices are provided sterile and non-pyrogenic and are intended for single use only. During use, a standard neurovascular guidewire may be inserted through the Delivery Catheter. The Delivery Catheter is inserted through a compatible catheter. The Delivery Catheter and compatible catheter are advanced to the targeted location under fluoroscopy using standard endovascular techniques.
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    K Number
    K182512
    Device Name
    Route 92 Medical Delivery Catheter
    Manufacturer
    Route 92 Medical Inc.
    Date Cleared
    2018-12-10

    (89 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Route 92 Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Route 92 Medical Delivery Catheter is indicated for use with compatible catheters in facilitating the insertion and guidance of catheters into a selected blood vessel in the neurovascular system.
    Device Description
    The Delivery Catheter is a single-lumen, variable stiffness catheter with a flexible, tapered tip delineated by two radiopaque markers. The distal shaft of the Delivery Catheter has a hydrophilic coating. On the proximal end is a hypotube attached to a luer hub for guidewire introduction. This proximal hypotube includes a fluoro-saver marker indicating when the tip of the catheter is about to exit a long femoral sheath/guide. The devices are provided sterile and non-pyrogenic and are intended for single use only. During use, a standard neurovascular guidewire may be inserted through the Delivery Catheter. The Delivery Catheter is inserted through a compatible access catheter. The Delivery Catheter and access catheter are advanced to the targeted location under fluoroscopy using standard endovascular techniques.
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