LimFlow V-Ceiver

The LimFlow V-Ceiver is a percutaneous snaring device intended for use in the cardiovascular system to manipulate and retrieve guidewires. It features a luer connector on the proximal end and a nitinol snaring basket at the distal end, with radiopaque markers for visibility and a coaxial sheath system to re-constrain the basket once a guidewire is captured.

The subject device and predicate device share identical key dimensions (4 Fr catheter OD, 1000 mm length, 6 mm basket OD) and design features, including a nitinol snare basket with radiopaque markers encased in polyimide sheath with inner nitinol and stainless-steel tubing. The only differences are in materials used in the distal tip component, packaging materials, and adhesives.

ISO 10993-1 (biocompatibility), ISO 11135:2014/A1:2018 (sterilization), ASTM F1886/F1886M-16, ASTM F2096-11(2019), ASTM F88/F88M-21, and ASTM D4169-22 (packaging validation).

There is no change to intended use, indications, principles of operation, or fundamental technological characteristics between the subject and predicate devices. Both devices have the same dimensions and identical design architecture (nitinol basket with markers, polyimide sheath, inner tubing). Material changes in the distal tip and packaging are minor and supported by biocompatibility, sterilization, and packaging validation testing that demonstrate the subject device maintains the same safety and performance profile as the predicate.