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510(k) Data Aggregation
K Number
K200582Device Name
Bendit2.7 Steerable Microcatheter
Manufacturer
Date Cleared
2020-06-25
(111 days)
Product Code
Regulation Number
870.1210Why 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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