510(k) K250147

CPS Locator 3D Delivery Catheter by Centerpoint Systems — Product Code DQY

K250147 is an FDA 510(k) premarket notification submitted by Centerpoint Systems for the device "CPS Locator 3D Delivery Catheter". The FDA issued a decision of Substantially Equivalent on August 22, 2025. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Centerpoint Systems has at least 10 other 510(k) clearances on record.