Cleared Special

K261766 - CPS Locator 3D Plus Delivery Catheter

K261766 is an FDA 510(k) clearance for CPS Locator 3D Plus Delivery Catheter, manufactured by CenterPoint Systems, LLC. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Special 510(k) pathway after a 62-day FDA review.

K261766 · CenterPoint Systems, LLC · Cardiovascular device
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Jul 2026
Decision
62d
Days
Class 2
Risk

K261766 is an FDA 510(k) clearance for the CPS Locator 3D Plus Delivery Catheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by CenterPoint Systems, LLC (West Valley City, US). The FDA issued a Cleared decision on July 29, 2026 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all CenterPoint Systems, LLC devices

FDA 510(k) Submission Details - K261766

510(k) Number K261766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2026
Decision Date July 29, 2026
Days to Decision 62 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 125d · This submission: 62d
Pathway characteristics
Modification to existing cleared device.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQY Catheter, Percutaneous

All 779
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