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510(k) Data Aggregation
(141 days)
The Bendit17 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.
The Bendit®17 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 Bendit®17 Microcatheter is 151 cm. It is comprised of two Nitinol hypo tubes that are connected at their distal ends, with proprietary laser-cut patterns along the 38 cm distal section. The laser cuts give the Bendit®17 Microcatheter its flexibility while maintaining the Nitinol torsional rigidity for a high torque response. The distal 10 mm section is steerable and includes two radiopaque markers, one at the tip and a radiopaque band located 30 mm proximally from the tip. The distal portion of the catheter shaft (100 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 Bendit®17 lumen can accommodate compatible guidewires (≤ 0.014 ''). A standard Luer lock port for attachment of accessories is located at the proximal end of the Steering Handle.
The Bendit®17 is compatible with the following types of therapeutic devices:
- Embolization particles with maximum particle size of 400 µm
- Coils with maximum coil wire size of 0.014''
- Stents/stent retrievers/intrasaccular flow disruption devices compatible with microcatheters with inner diameter of 0.017''
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