Cleared Traditional

K123714 - EDWARDS EMBOL-X INTRODUCER SHEATH

K123714 is an FDA 510(k) clearance for EDWARDS EMBOL-X INTRODUCER SHEATH, manufactured by Edwards Lifesciences, LLC. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K123714 · Edwards Lifesciences, LLC · Cardiovascular device
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Jul 2013
Decision
232d
Days
Class 2
Risk

K123714 is an FDA 510(k) clearance for the EDWARDS EMBOL-X INTRODUCER SHEATH. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Edwards Lifesciences, LLC (Draper, US). The FDA issued a Cleared decision on July 24, 2013 after a review of 232 days - an extended review 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: 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, LLC devices

FDA 510(k) Submission Details - K123714

510(k) Number K123714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2012
Decision Date July 24, 2013
Days to Decision 232 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
107d slower than avg
Panel avg: 125d · This submission: 232d
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 432
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K123714.
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K123990 · Medtronic Vascular · Apr 2013
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K123235 · Cook Incorporated · Feb 2013