Cleared Special

CPS Locator 3D Delivery Catheter

K230363 · CenterPoint Systems, LLC · Cardiovascular
Mar 2023
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K230363 is an FDA 510(k) clearance for the CPS Locator 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 March 9, 2023, 27 days after receiving the submission on February 10, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K230363 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 2023
Decision Date March 09, 2023
Days to Decision 27 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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