Cleared Traditional

CPS Locator 3D Delivery Catheter

K250147 · Centerpoint Systems · Cardiovascular

Aug 2025

Decision

213d

Days

Class 2

Risk

About This 510(k) Submission

K250147 is an FDA 510(k) clearance for the CPS Locator 3D Delivery Catheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Centerpoint Systems (West Valley City, US). The FDA issued a Cleared decision on August 22, 2025, 213 days after receiving the submission on January 21, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K250147 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 21, 2025
Decision Date	August 22, 2025
Days to Decision	213 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF