Cleared Traditional

K250147 - CPS Locator 3D Delivery Catheter

K250147 is an FDA 510(k) clearance for CPS Locator 3D Delivery Catheter, manufactured by Centerpoint Systems. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K250147 · Centerpoint Systems · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
213d
Days
Class 2
Risk

K250147 is an FDA 510(k) clearance for the CPS Locator 3D Delivery Catheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Centerpoint Systems (West Valley City, US). The FDA issued a Cleared decision on August 22, 2025 after a review of 213 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Centerpoint Systems devices

FDA 510(k) Submission Details - K250147

510(k) Number K250147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 125d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 621
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K250147.
C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)
K253409 · Medtronic, Inc. · Dec 2025
Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)
K252417 · Abbott Medical · Dec 2025
Telescope Guide Extension Catheter
K252390 · Medtronic, Ireland · Oct 2025
CoraForce Microcatheter, CoraFlex Microcatheter
K251277 · Reflow Medical, Inc. · Aug 2025
Primum Hydrophilic Guiding Catheter
K250972 · Pendracare · Jun 2025
CPS Locator 3D Plus Delivery Catheter
K250828 · CenterPoint Systems, LLC · Jun 2025