Cleared Traditional

K032900 - LIFESPAN REINFORCED EPTFE STRAIGHT VASC...

K032900 is an FDA 510(k) clearance for LIFESPAN REINFORCED EPTFE STRAIGHT VASC..., manufactured by Edwards Lifesciences, LLC. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K032900 · Edwards Lifesciences, LLC · Cardiovascular device
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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

FDA 510(k) Submission Details - K032900

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
Combination Product No
PCCP Authorized No
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.

DSY Device Classification - Class 2, Special Controls

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 125
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K032900.
MODIFICATION TO EPTFE GRAFT
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ADVANTA SST BIFURCATED GRAFT
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ULTRAMAX WOVEN VELOUR VASCULAR GRAFT
K013577 · Atrium Medical Corp. · Jan 2002