Cleared Special

AuST CSP Introducer

K260163 · CenterPoint Systems, LLC · Cardiovascular
Feb 2026
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K260163 is an FDA 510(k) clearance for the AuST CSP Introducer, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by CenterPoint Systems, LLC (West Valley City, US). The FDA issued a Cleared decision on February 19, 2026, 30 days after receiving the submission on January 20, 2026. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K260163 FDA.gov
FDA Decision Cleared SESE
Date Received January 20, 2026
Decision Date February 19, 2026
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DYB — Introducer, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1340

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