Cleared Traditional

ViaOne Epicardial Access System (K243928) - FDA 510(k) Clearance

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

K243928 · Cardiovia , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2025
Decision
90d
Days
Class 2
Risk

K243928 is an FDA 510(k) clearance for the ViaOne Epicardial Access System. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Cardiovia , Ltd. (Nazareth, IL). The FDA issued a Cleared decision on March 20, 2025 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cardiovia , Ltd. devices

Submission Details

510(k) Number K243928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2024
Decision Date March 20, 2025
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
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 284
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K243928.
Prelude Wave Hydrophilic Sheath Introducer
K250909 · Merit Medical Systems, Inc. · Apr 2025
PeriCross™ Epicardial Access Kit
K243954 · Circa Scientific, Inc. · Apr 2025
Edwards eSheath Optima introducer set
K244046 · Edwards Lifesciences · Mar 2025
iSLEEVE Introducer Set
K250468 · Boston Scientific · Mar 2025
Catapult Guide Sheath
K250439 · Contract Medical International, GmbH · Mar 2025
Agilis NxT Steerable Introducer Dual-Reach
K243493 · Abbott Medical · Dec 2024