Cleared Traditional

K032900 - LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTS (FDA 510(k) Clearance)

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

K032900 · Edwards Lifesciences, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
78d
Days
Class 2
Risk

K032900 is an FDA 510(k) clearance for the LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASC.... Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on December 4, 2003 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3450 - 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 K032900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2003
Decision Date December 04, 2003
Days to Decision 78 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
47d faster than avg
Panel avg: 125d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3450
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 - DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

All 187
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K032900.
Fusion Bioline Vascular Graft
K252445 · Maquet Cardiovascular, LLC · Apr 2026
Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)
K252277 · Vascular Flow Technologies Limited · Oct 2025
Gelweave™ Vascular Prostheses
K241550 · Vascutek, Ltd. · Feb 2025
Gelsoft™ Plus Vascular Prostheses
K241070 · Vascutek, Ltd. · Nov 2024
Advanta VXT Vascular Graft, Flixene Vascular Graft
K231972 · Atrium Medical Corporation · Mar 2024
GORE® PROPATEN® Vascular Graft
K240083 · W.L. Gore & Associates, Inc. · Mar 2024