CPS Locator 3D Delivery Catheter— 510(k) K250147

Name: FDA 510(k) clearance K250147
Creator: U.S. Food and Drug Administration
Published: 2025-08-22

Substantially Equivalent

Centerpoint Systems

FDA 510(k) clearance K250147 for CPS Locator 3D Delivery Catheter, Substantially Equivalent on 2025-08-22. Applicant: Centerpoint Systems. Device class: 2.

Clearance details

Applicant: Centerpoint Systems
Product code: Code DQY
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2025-01-21
Decision date: 2025-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Valley City, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DQY

view all

K260559 — NHanceIT2026-08-14
K262392 — APRO 35 Swift Catheter2026-08-12
K261766 — CPS Locator 3D Plus Delivery Catheter2026-07-29
K262240 — SSPC NXT Delivery Catheter2026-07-29
K261825 — Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter2026-07-02

More clearances from Centerpoint Systems

view all

K190475 — Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC42019-06-28

Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.