Cleared Traditional

K121185 - EDWARDS PERCUTANEOUS SHEATH INTRODUCER

K121185 is an FDA 510(k) clearance for EDWARDS PERCUTANEOUS SHEATH INTRODUCER, 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 126-day FDA review.

K121185 · Edwards Lifesciences, LLC · Cardiovascular device
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Aug 2012
Decision
126d
Days
Class 2
Risk

K121185 is an FDA 510(k) clearance for the EDWARDS PERCUTANEOUS SHEATH INTRODUCER. 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 August 22, 2012 after a review of 126 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, LLC devices

FDA 510(k) Submission Details - K121185

510(k) Number K121185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2012
Decision Date August 22, 2012
Days to Decision 126 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 125d · This submission: 126d
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 K121185.
STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO
K122960 · Oscor, Inc. · Dec 2012
GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING
K121234 · W.L. Gore & Associates, Inc. · Nov 2012
INTRODUCER SET, MODEL ADELANTE-S SERIES
K122084 · Oscor, Inc. · Aug 2012
PRELUDE 7F SHORT SHEATH INTRODUCER
K122190 · Merit Medical Systems, Inc. · Aug 2012
CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS
K120158 · Thomas Medical Products, Inc. · Aug 2012
STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO
K120459 · Oscor, Inc. · Jun 2012