CPS Locator 3D Plus Delivery Catheter

The CPS Locator 3D Plus Delivery Catheter is a single-use percutaneous catheter designed to introduce various types of catheters and pacing or defibrillator leads into the vasculature. It features a hemostatic valve at the proximal end, a soft radiopaque distal tip for fluoroscopic visualization, and is slittable for removal after device placement.

The subject device has an outer diameter of 10.2F and inner diameter of 8.4F, compared to the predicate's 9F and 7F respectively. Both devices use 0.035" guidewire compatibility, PEBAX shaft material with barium sulfate, hydrophilic liners, braid reinforcement, and are sterilized via E-beam to SAL 10⁻⁶. Working lengths, components, valve presence, and principles of operation are identical between the two.

Biocompatibility per FDA guidance on ISO 10993-1; sterilization validation per ISO 11137; packaging validation per ANSI/AAMI/ISO 11607-1; simulated use testing; valve liquid leak testing; tensile testing; dimensional verification; and flush testing.

The subject device uses identical intended use, indications, product code, and principles of operation as the predicate K230363. The modest increases in outer and inner diameter (10.2F vs. 9F, 8.4F vs. 7F) do not introduce new safety or effectiveness concerns because all other critical design features—materials, sterilization, guidewire compatibility, and functional components—remain unchanged. All performance testing confirms the device performs as intended with substantially equivalent characteristics.