Cleared Traditional

AuST Steerable Sheath (K240829) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K240829 · CenterPoint Systems, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
36d
Days
Class 2
Risk

K240829 is an FDA 510(k) clearance for the AuST Steerable Sheath. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by CenterPoint Systems, LLC (West Valley City, US). The FDA issued a Cleared decision on May 1, 2024 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all CenterPoint Systems, LLC devices

Submission Details

510(k) Number K240829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 125d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DYB Introducer, Catheter

All 272
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K240829.
Abiomed 14Fr Low Profile Introducer Kit
K241708 · Abiomed, Inc. · Aug 2024
TLAB® Transvenous Liver Biopsy System (TF-18C)
K241145 · Argon Medical Devices, Inc. · Aug 2024
Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED)
K241370 · Abbott Medical · Jun 2024
Micropuncture Introducer Sets
K240589 · Cook, Medical · Mar 2024
NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)
K233708 · Synaptic Medical Corporation · Feb 2024
EPi-Ease Epicardial Access Device (EAS)
K233959 · AtriCure, Inc. · Feb 2024