Cleared Special

FlexiGo 3D Delivery Catheter

K250492 · CenterPoint Systems, LLC · Cardiovascular
Jun 2025
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K250492 is an FDA 510(k) clearance for the FlexiGo 3D Delivery Catheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by CenterPoint Systems, LLC (West Valley City, US). The FDA issued a Cleared decision on June 18, 2025, 118 days after receiving the submission on February 20, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K250492 FDA.gov
FDA Decision Cleared SESE
Date Received February 20, 2025
Decision Date June 18, 2025
Days to Decision 118 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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