Cleared Special

K162184 - Edwards eSheath Introducer Set

K162184 is an FDA 510(k) clearance for Edwards eSheath Introducer Set, manufactured by Edward Lifesciences. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Special 510(k) pathway after a 29-day FDA review.

K162184 · Edward Lifesciences · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
29d
Days
Class 2
Risk

K162184 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 Edward Lifesciences (Irvine, US). The FDA issued a Cleared decision on September 2, 2016 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K162184

510(k) Number K162184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2016
Decision Date September 02, 2016
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 662
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K162184.
the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model
K162322 · Access Scientific, LLC · Nov 2016
Pinpoint GT Introducer Needle
K162769 · C.R. Bard, Inc. · Nov 2016
TXM Guiding Sheath
K153771 · Texasmedical Technologies, Inc. · Sep 2016
HQS Introducer (Model 2064-HQS)
K153494 · Alseal · Aug 2016
GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle
K152913 · Creganna Medical Aslo Business AS Cregganna Tactx Medical · Jul 2016
FlexSeal Introducer Sheath with Hydrophilic Coating
K161659 · Libramedical, Inc. · Jul 2016