Cleared Traditional

K131627 - CATHETER INTRODUCER SHEATH

K131627 is an FDA 510(k) clearance for CATHETER 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 275-day FDA review.

K131627 · Edwards Lifesciences, LLC · Cardiovascular device
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Mar 2014
Decision
275d
Days
Class 2
Risk

K131627 is an FDA 510(k) clearance for the CATHETER 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 March 6, 2014 after a review of 275 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 - K131627

510(k) Number K131627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2013
Decision Date March 06, 2014
Days to Decision 275 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
150d slower than avg
Panel avg: 125d · This submission: 275d
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 K131627.
DESTINO TWIST, STEERABLE GUIDING SHEATH
K140406 · Oscor, Inc. · Apr 2014
EMBOL-X INTRODUCER SHEATH
K140398 · Edwards Lifesciences, LLC · Mar 2014
ULTIMUM EV HEMOSTASIS INTRODUCER
K140327 · St Jude Medical · Mar 2014
INTRODUCER SETS, MODEL ADELANTE RADIAL
K130633 · Oscor, Inc. · Feb 2014
HEARTSPAN FIXED CURVE BRAIDED TRANSSEPTAL SHEATH
K132720 · Merit Medical Systems, Inc. · Feb 2014
MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING
K132030 · Medtronic, Inc. · Sep 2013