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510(k) Data Aggregation

    K Number
    K191305
    Device Name
    Hereaeus Poseidon Microcatheter
    Manufacturer
    Heraeus Medical Components, LLC
    Date Cleared
    2019-12-19

    (219 days)

    Product Code
    KRA, DQY
    Regulation Number
    870.1210
    Why did this record match?
    Applicant Name (Manufacturer) :

    Heraeus Medical Components, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Poseidon Microcatheter is intended for use in peripheral and coronary vessels for diagnostic and interventional procedures including small or superselective anatomy.
    Device Description
    The Poseidon Microcatheter is a single lumen catheter constructed using an internal lubricious layer encapsulated by a metallic braid and lubricious outer layer. The distal tip includes a radiopaque marker band, and the distal 60 - 90 cm of the microcatheter has a hydrophilic coating.
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    K Number
    K191502
    Device Name
    Heraeus Peripheral Guidewire
    Manufacturer
    Heraeus Medical Components, LLC
    Date Cleared
    2019-11-26

    (173 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    Heraeus Medical Components, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended to facilitate the placement of balloon dilation catheters during percutaneous transluminal angioplasty (PTA), in peripheral arteries including but not limited to femoral, popliteal arteries. This guide wire may also be used with compatible interventional devices during therapeutic procedures. The guide wire may also be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.
    Device Description
    The Heraeus Peripheral Guidewire is a guidewire constructed using a steel core with an optional nitinol alloy tip encapsulated by polymer and lubricious outer layer. The distal polymer includes a radiopaque loading, and the distal polymer section has a hydrophilic coating.
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    K Number
    K170664
    Device Name
    Odyssey Micro Catheter
    Manufacturer
    Heraeus Medical Components, LLC
    Date Cleared
    2017-11-09

    (248 days)

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

    Heraeus Medical Components, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Odyssey Micro Catheter is intended to provide support to facilitate the placement of guidewires in the coronary and peripheral vasculatures and can be used to exchange one guide wire for another. The Odyssey Micro Catheter is also intended to assist in the infusion of contrast media. The micro catheter is not intended to be used in the neurovasculature.
    Device Description
    The Odyssey Micro Catheter is a single lumen catheter constructed using a PTFE liner inside of metallic coil and a polymer outer layer. The distal tip is a radiopaque polymer material and the distal 30 cm to 60 cm of the micro catheter has a hydrophilic coating. The key components of the catheter are the core, coil(s), tip, and coatings.
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    K Number
    K173052
    Device Name
    Heraeus TMW Guidewire
    Manufacturer
    Heraeus Medical Components, LLC
    Date Cleared
    2017-10-20

    (22 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    Heraeus Medical Components, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Heraeus TMW Guidewire is intended to facilitate the introduction and placement of catheters and interventional devices during Percutaneous Transluminal Angioplasty (PTA) and/or Percutaneous Transluminal Coronary Angioplasty (PTCA).
    Device Description
    Heraeus TMW Guidewire is a steerable guidewire constructed of a bi-metal core wire. The distal core is made of Triton™ Nitinol alloy and has a coiled wire feature at the distal end. The proximal core is comprised of PTFE coated Stainless Steel material. The wire is available in .014" diameter and lengths ranging from 180 to 300 cm. The distal segment is coated with hydrophilic coating and is shapeable with a 3 cm radiopaque distal tip.
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