LimFlow Vector

The LimFlow Vector is a single-use medical device designed to cut venous valves during vascular in-situ bypass procedures. It is a 4Fr intravascular catheter with a 120 cm working length that deploys a self-expanding nitinol cutting basket at its distal tip to excise or disrupt venous valves while protecting the vessel wall.

The subject and predicate devices share the same three primary elements (Y-connector/hemostasis valve, catheter shaft, cutting basket) and key features (4Fr sheath compatibility, 0.018" guide wire compatibility, self-centering cutting basket). Key differences include replacement of the strain relief bond with a y-hub to catheter shaft bond, removal of the stopcock component, material changes in the distal tip, y-hub, basket, luer, and adhesives, and minor packaging material changes.

ISO 10993-1 (biocompatibility), ISO 11135:2014/Amd 1:2018 (sterilization), ASTM F1886/F1886M-16, ASTM F2096-11(2019), ASTM F88/F88M-21, and ASTM D4169-22 (packaging validation).

There is no change to the intended use, principles of operation, or fundamental scientific technology between the subject and predicate devices. Both have similar materials and dimensions. Performance testing including biocompatibility, design verification, sterilization, and packaging validation demonstrate the modified device continues to meet design requirements and substantial equivalence to the predicate.