CPS Locator 3D Plus Delivery Catheter— 510(k) K261766
Substantially EquivalentCenterPoint Systems, LLC
FDA 510(k) clearance K261766 for CPS Locator 3D Plus Delivery Catheter, Substantially Equivalent on 2026-07-29. Applicant: CenterPoint Systems, LLC. Device class: 2.
Summary
CenterPoint Systems' CPS Locator 3D Plus Delivery Catheter is filed under DQY, percutaneous catheters. The record doesn't give the catheter's dimensions or expand "CPS".
Class II, 21 CFR 870.1250. Cardiovascular is both the classification panel and the review panel. It came in as a Special 510(k).
CenterPoint Systems filed from West Valley City, Utah. The decision came 62 calendar days after FDA received it (May 28 to July 29, 2026).
Clearance details
- Applicant
- CenterPoint Systems, LLC
- Product code
- Product code DQY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- West Valley City, UT, US
Recent devices under product code DQY
view allMore clearances from CenterPoint Systems, LLC
view allAdverse 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, through . 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.