Cleared Traditional

AuST Steerable Sheath

K240829 · CenterPoint Systems, LLC · Cardiovascular
May 2024
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K240829 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 May 1, 2024, 36 days after receiving the submission on March 26, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K240829 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2024
Decision Date May 01, 2024
Days to Decision 36 days
Submission Type Traditional
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