Cleared Traditional

K254279 - Edwards eSheath+ introducer set (FDA 510(k) Clearance)

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

K254279 · Edwards Lifesciences · Cardiovascular device
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Apr 2026
Decision
108d
Days
Class 2
Risk

K254279 is an FDA 510(k) clearance for the Edwards eSheath+ introducer set. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Edwards Lifesciences (Irvine, US). The FDA issued a Cleared decision on April 17, 2026 after a review of 108 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 Edwards Lifesciences devices

Submission Details

510(k) Number K254279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2025
Decision Date April 17, 2026
Days to Decision 108 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
17d faster than avg
Panel avg: 125d · This submission: 108d
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 700
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K254279.
Echo Large Bore Introducer Sheath
K260606 · Echo Medical, LLC · Apr 2026
Introducer Sheath Set
K254248 · Cardiocycle Medical(Suzhou) Co., Ltd. · Apr 2026
Aventus Introducer Sheath
K260091 · Inquis Medical · Apr 2026
Protaryx Transseptal Puncture Device (PTX2-001)
K260839 · Protaryx Medical, Inc. · Apr 2026
AuST Steerable Sheath
K260942 · CenterPoint Systems, LLC · Apr 2026
VANES Delivery System (VDS)
K260459 · Zoll Respicardia, Inc. · Apr 2026