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510(k) Data Aggregation

    K Number
    K203842
    Device Name
    Bendit21 Microcatheter
    Date Cleared
    2022-04-13

    (468 days)

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

    Bend It Technologies Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bendit®21 Microcatheter is intended for use in accessing target locations in the peripheral, coronary, and neuro vasculature and can be used to deliver both diagnostic agents, such as contrast media, and therapeutic devices. Use only contrast media and therapeutic devices that have been cleared or approved for use in the intended target area.
    Device Description
    The Bendit21 Microcatheter is a steerable microcatheter with a steerable distal tip. The tip's deflection is controlled using the Steering Slider on the proximal Steering Handle. The tip can be rotated bi-directionally while deflected by turning the Torque Knob on the Steering Handle. The total working length of the Bendit21 Microcatheter is 157 cm. It is comprised of two Nitinol hypo tubes that are welded together at their distal ends, with proprietary laser -cut patterns along the 36 cm distal section. The laser cuts give the Bendit21 Microcatheter its flexibility while maintaining the Nitinol torsional rigidity for a high torque response. The distal 12 mm section is steerable using the proximal Steering Handle. The device includes two radiopaque markers, one at the tip and a radiopaque band located 30 mm from the tip. The distal portion of the catheter shaft (75 cm) is covered with a hydrophilic coating. Sliding the Steering Slider forward moves the hypo tubes so that the distal tip deflects. When the Steering Slider is released, the tip shape is locked. The Bendit21 lumen can accommodate compatible guidewires (≤ 0.018 ''). A standard Luer lock port for attachment of accessories is located at the proximal end of the Steering Handle. The Bendit21 Microcatheter is compatible with the following types of therapeutic devices: Embolization particles with maximum particle size of 500 µm, Coils with maximum coil wire size of 0.018", Stents/Stent Retrievers/Flow Diverters.
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    K Number
    K200582
    Device Name
    Bendit2.7 Steerable Microcatheter
    Date Cleared
    2020-06-25

    (111 days)

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

    Bend It Technologies Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bendit2.7 Steerable Microcatheter is intended for general intravascular use in the peripheral vasculature. The microcatheter can be used for the delivery of diagnostic, embolic materials into the vasculature. The Bendit2.7 is not intended to be used in intracranial or coronary vessels.
    Device Description
    The Bendit2.7™ is a steerable microcatheter with a steerable distal tip. The tip's deflection is controlled using the Steering Slider on the proximal Steering Handle. The tip can be rotated bi-directionally while deflected by turning the Torque Knob on the Steering Handle. The total working length of the Bendit2.7™ is 130 cm. It is comprised of two Nitinol hypo tubes that are welded together at their distal ends, with proprietary laser-cut patterns along the 28-centimeter distal section. The laser cuts give the Bendit2.7™ its flexibility while maintaining the Nitinol torsional rigidity for a high torque response. The distal 12 mm section is steerable and includes a radiopaque atraumatic tip. The distal 80 cm of the shaft is covered with a hydrophilic coating. Sliding the Steering Slider forward moves the hypo tubes so that the distal tip deflects. When the Steering Slider is released, the tip shape is locked. The Bendit2.7™ lumen can accommodate compatible guidewires (≤0.018"). A standard Luer lock port for attachment of accessories is located at the proximal end of the Steering Handle.
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    K Number
    K190126
    Device Name
    Bendit2.7 Steerable Microcatheter
    Date Cleared
    2019-08-22

    (206 days)

    Product Code
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bend It Technologies Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bendit2.7 Steerable Microcatheter is intended for general intravascular use in the peripheral vasculature. The microcatheter can be used for the delivery of diagnostic, embolic, or therapeutic materials into the vasculature. The Bendit2.7 is not intended to be used in intracranial or coronary vessels.
    Device Description
    The Bendit2.7™ is a steerable microcatheter with a steerable distal tip. The tip's deflection is controlled using the Steering Slider on the proximal Steering Handle. The tip can be rotated bi-directionally while deflected by turning the Torque Knob on the Steering Handle. The total working length of the Bendit2.7™ is 130 cm. It is comprised of two Nitinol hypo tubes that are welded together at their distal ends, with proprietary laser-cut patterns along the 28-centimeter distal section. The laser cuts give the Bendit2.7™ its flexibility while maintaining the Nitinol torsional rigidity for a high torque response. The distal 12 mm section is steerable and includes a radiopaque atraumatic tip. The shaft is covered with a hydrophilic coating. Sliding the Steering Slider forward moves the hypo tubes so that the distal tip deflects. When the Steering Slider is released, the tip shape is locked. The Bendit2.7™ lumen can accommodate compatible guidewires (≤0.018"). A standard Luer lock port for attachment of accessories is located at the proximal end of the Steering Handle.
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