CPS Locator 3D Delivery Catheter

CPS Locator 3D Delivery Catheter is an FDA 510(k)-cleared medical device (K250147) manufactured by Centerpoint Systems. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 21, 2025. Regulation: 8.