CPS Locator 3D Delivery Catheter

The CPS Locator 3D Delivery Catheter is a single-use percutaneous catheter designed to introduce pacing and defibrillation leads into the right heart, including the left bundle branch area. It features a hemostatic valve, radiopaque distal tip for fluoroscopic visualization, and is slittable to allow removal after lead placement.

The subject device has a 7F inner diameter (compared to 6.5F in the predicate), but shares identical outer diameter (9.0F), guidewire compatibility (0.035 inch), working lengths (42cm, 45cm), materials (PEBAX with barium sulfate), sterilization method (e-beam, SAL 10⁻⁶), and all other structural features including braid reinforcement, hemostatic valve, and dilator components.

Biocompatibility per ISO 10993-1; sterilization validation per ISO 11137; packaging validation per ANSI/AAMI/ISO 11607-1; and performance testing including simulated use, valve leak testing, tensile testing, dimensional verification, and flush testing.

The subject device is substantially equivalent because it maintains identical intended use, indications for use (right heart lead delivery), anatomical location, and principles of operation as the predicate K230363. The only material difference is the increased inner diameter (7F vs 6.5F), which actually enhances lead delivery capability without raising new safety or effectiveness questions. Post-market clinical data from real-world use demonstrates successful lead delivery to the left bundle branch area in 95% of cases with no reported adverse events, confirming safe and effective performance consistent with the predicate.