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510(k) Data Aggregation

    K Number
    K251212
    Device Name
    Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)
    Manufacturer
    Access Vascular, Inc.
    Date Cleared
    2025-07-01

    (74 days)

    Product Code
    LJS
    Regulation Number
    880.5970
    Why did this record match?
    Applicant Name (Manufacturer) :

    Access Vascular, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K244059
    Device Name
    HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104)
    Manufacturer
    Access Vascular, Inc.
    Date Cleared
    2025-03-27

    (86 days)

    Product Code
    FOZ
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Access Vascular, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HydroMID 5F Dual Lumen Midline Catheter is indicated for short term access (< 30 days) to the peripheral venous access system for intravenous therapy, including but not limited to, the administration of fluids, medications, and the sampling of blood and blood products. Rated for maximum power injection flow rate of 6ml/s.
    Device Description
    The HydroMID catheter is a 5 French, dual lumen, midline catheter comprised of a radiopaque, hydrophilic catheter with a suture wing, Luer lock hub, and extension tubing made from materials commonly used in the manufacture of catheters. Catheters are provided packaged in kit configurations with the appropriate accessories for placement in the respective clinical environments. HydroMID has been shown to be effective in reducing thrombus accumulation and thrombotic occlusions. Reduction of thrombus accumulation and thrombotic occlusions were evaluated using in vitro and in vivo models. Pre-clinical in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation. Catheter and accessories are supplied sterile. Product is sterilized by ethylene oxide (EO) except where labeled otherwise. Product should be stored in a cool, dry, dark place. The HydroMID Catheter is supplied in a dry state and must be hydrated before use.
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    K Number
    K243941
    Device Name
    HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001202); HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204); HydroPICC 4Fr Single Lumen Marked catheter, Mobile Maximal Barrier Kit (90001204)
    Manufacturer
    Access Vascular, Inc.
    Date Cleared
    2025-01-17

    (28 days)

    Product Code
    LJS
    Regulation Number
    880.5970
    Why did this record match?
    Applicant Name (Manufacturer) :

    Access Vascular, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated for short-or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media. Rated for maximum power injection flow rate of 5.0ml/s
    Device Description
    The HydroPICC 4F Single Lumen Catheter is comprised of a radiopaque hydrophilic catheter material with a suture wing, Luer lock hub, and extension tubing made from materials commonly used in the manufacture of catheters are provided packaged in kit configurations with the appropriate accessories for placement in the respective clinical environments. The maximum power injection flow rate for the lumen is indicated on the clamp. HydroPCC has been shown to be effective in reducing thrombus accumulation and thrombotic occlusions f thrombus accumulation and thrombotic occusions were evaluated using in vitro and in vivo models. Pre-clinical in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.
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    K Number
    K220772
    Device Name
    HydroMID 4F Single Lumen Midline Catheter
    Manufacturer
    Access Vascular, Inc.
    Date Cleared
    2022-12-07

    (266 days)

    Product Code
    FOZ
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Access Vascular, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HydroMID is indicated for short term access (< 30 days) to the peripheral venous access system for intravenous therapy, including but not limited to, the administrations, and the sampling of blood and blood products. Maximum Power Injection Flow Rate: -4Fr Single Lumen, 20cm: 6 mL/sec
    Device Description
    The HydroMID catheter is a 4 French, single lumegemidfifie catheter comprised of a radiopaque, hydrophilic catheter with a suture wing, Luer lock hub, and extension tube made from materials commonly used in the manufacture of catheters. Catheters are provided packaged in kit configurations with the appropriate accessories for placement in the appropriate clinical environments. The maximum power injection flow rate for the lumen is indicated on the extension tube clamp. HydroMID has been shown to be effective in reducing thrombus accumulation and thrombotic occlusions. Reduction of thrombus accumulation and thrombotic occlusions were evaluated using in vitro and in vivo models. Pre-clinical in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.
    Ask a Question

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