Cleared Special

AuST Steerable Sheath

K251051 · CenterPoint Systems, LLC · Cardiovascular
Apr 2025
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K251051 is an FDA 510(k) clearance for the AuST Steerable Sheath, 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 April 30, 2025, 27 days after receiving the submission on April 3, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K251051 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 2025
Decision Date April 30, 2025
Days to Decision 27 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