FlexiGo 3D Delivery Catheter

The FlexiGo 3D Delivery Catheter is a single-use percutaneous catheter designed for venous introduction of pacing or defibrillation leads. It features a hemostatic valve, soft radiopaque tip for fluoroscopic imaging, and is slittable to allow removal after device placement. Multiple curves and lengths are available to accommodate different anatomies.

The device is substantially equivalent to the predicate in most features. Key differences include: outer diameter options of 8.0F and 9.5F (vs. predicate 8.0F only); inner diameter options of 5.9F and 7.4F (vs. predicate 6.5F); working lengths of 40cm, 41cm, and 45cm (vs. predicate 40cm only); and inclusion of two transvalvular introducers in the package (vs. predicate without TVIs). Both use PEBAX shaft material with barium sulfate, braid reinforcement, hydrophilic liner, and e-beam sterilization at SAL 10⁻⁶.

ISO 10993-1 (biocompatibility evaluation), ISO 11137 (sterilization validation), ANSI/AAMI/ISO 11607-1 (packaging validation). Additional testing included visual inspection, simulated use testing, valve liquid leak test, tensile tests, dimensional verification, and flush test.

The subject device uses the same intended use (lead delivery), anatomical location, principles of operation, and predicate device (SSPC Delivery Catheter, K190475). The dimensional and component differences are minor and do not raise new safety or effectiveness questions—the predicate demonstrates safety and effectiveness for lead delivery, and the subject device operates identically with only incremental variations in size and included accessories. All required performance testing was passed.