Cleared Traditional

K152225 - Edwards eSheath Introducer Set

K152225 is an FDA 510(k) clearance for Edwards eSheath Introducer Set, manufactured by Edwards Lifesciences. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K152225 · Edwards Lifesciences · Cardiovascular device
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Nov 2015
Decision
109d
Days
Class 2
Risk

K152225 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 November 24, 2015 after a review of 109 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

FDA 510(k) Submission Details - K152225

510(k) Number K152225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2015
Decision Date November 24, 2015
Days to Decision 109 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
16d faster than avg
Panel avg: 125d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

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 646
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K152225.
SoloPath Re-Collapsible Access System
K152498 · Onset Medical Corporation · Jan 2016
Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle
K151936 · Synaptic Medical Limited · Dec 2015
Glidesheath
K152173 · Terumo Medical Corporation · Dec 2015
Prelude SNAP Splittable Hydrophilic Sheath Introducer
K152381 · Merit Medical Systems, Inc. · Oct 2015
SonoStik IV Guide Wire Introducer
K152177 · Sonostik, LLC · Oct 2015
Destino Reach
K151951 · Oscor, Inc. · Sep 2015