Cleared Traditional

OCHSNER 500 VASCULAR PROSTHESIS (K905269) - FDA 510(k) Clearance

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

K905269 · Intervascular, Inc. · Cardiovascular device
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Apr 1991
Decision
130d
Days
Class 2
Risk

K905269 is an FDA 510(k) clearance for the OCHSNER 500 VASCULAR PROSTHESIS. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Intervascular, Inc. (Clearwater, US). The FDA issued a Cleared decision on April 2, 1991 after a review of 130 days - within the typical 510(k) review window.

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: 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 Intervascular, Inc. devices

Submission Details

510(k) Number K905269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1990
Decision Date April 02, 1991
Days to Decision 130 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 125d · This submission: 130d
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 56
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K905269.
FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT
K922905 · W.L. Gore & Associates, Inc. · Nov 1992
PLASMA TFE SYNTHETIC ARTERY-CLARIFICATION
K914116 · Medtronic Vascular · Nov 1991
GORE-TEX(R) VASCULAR GRAFTS, PROCESS CHANGE
K914447 · W.L. Gore & Associates, Inc. · Nov 1991
BIFURCATED GORE TEX STRETCH VASCULAR GRAFT
K904282 · W.L. Gore & Associates, Inc. · Jan 1991
GORE-TEX(R) STRETCH VASCULAR GRAFT
K903931 · W.L. Gore & Associates, Inc. · Dec 1990
AXILLOBIFEMORAL GORE-TEX VASCULAR GRAFT
K901641 · W.L. Gore & Associates, Inc. · Sep 1990