Cleared Traditional

EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL (K030944) - FDA 510(k) Clearance

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

K030944 · Edwards Lifesciences, LLC · Cardiovascular device
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Jun 2003
Decision
86d
Days
Class 2
Risk

K030944 is an FDA 510(k) clearance for the EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on June 20, 2003 after a review of 86 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, LLC devices

Submission Details

510(k) Number K030944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2003
Decision Date June 20, 2003
Days to Decision 86 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
39d faster than avg
Panel avg: 125d · This submission: 86d
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 K030944.
CAPTIVA BLOOD CONTAINMENT DEVICE CN100, CAN19T71W
K031922 · Merit Medical Systems, Inc. · Oct 2003
GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE
K032073 · W.L. Gore & Associates, Inc. · Aug 2003
SAFETY INTRODUCER NEEDLE
K030135 · B.Braun Medical, Inc. · Jul 2003
EDWARDS INTRODUCER SHEATH
K031087 · Edwards Lifesciences, LLC · Apr 2003
INTROCAN SAFETY IV CATHETER
K021094 · B.Braun Medical, Inc. · Jul 2002
EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL
K014052 · Edwards Lifesciences, LLC · Mar 2002