Cleared Traditional

Edwards eSheath Introducer Set (K200258) - FDA 510(k) Clearance

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

K200258 · Edwards Lifesciences · Cardiovascular device
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Mar 2020
Decision
35d
Days
Class 2
Risk

K200258 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 March 9, 2020 after a review of 35 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 Edwards Lifesciences devices

Submission Details

510(k) Number K200258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2020
Decision Date March 09, 2020
Days to Decision 35 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
90d faster than avg
Panel avg: 125d · This submission: 35d
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 K200258.
Fortress Introducer Sheath System
K203179 · Contract Medical International, GmbH · Nov 2020
iSleeve Introducer Set
K202584 · Boston Scientific Corporation · Oct 2020
Abiomed 23 Fr Sheath
K201116 · Abiomed, Inc. · Jun 2020
AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX
K193509 · Acutus Medical, Inc. · Jan 2020
R2P Destination Slender Guiding Sheath
K193125 · Terumo Medical Corporation · Jan 2020
Halo One Thin-Walled Guiding Sheath
K192313 · C.R. Bard, Inc. · Dec 2019