Cleared Special

AuST Steerable Sheath

K242106 · CenterPoint Systems, LLC · Cardiovascular
Oct 2024
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K242106 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 October 4, 2024, 78 days after receiving the submission on July 18, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K242106 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 2024
Decision Date October 04, 2024
Days to Decision 78 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