Cleared Traditional

OCHSNER 50 BIFURCATION (K903964) - FDA 510(k) Clearance

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

K903964 · Intervascular, Inc. · Cardiovascular device
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Dec 1990
Decision
97d
Days
Class 2
Risk

K903964 is an FDA 510(k) clearance for the OCHSNER 50 BIFURCATION. 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 December 3, 1990 after a review of 97 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 K903964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1990
Decision Date December 03, 1990
Days to Decision 97 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 125d · This submission: 97d
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 K903964.
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
PLASMA TFE VASCULAR PROSTHESIS MODIFIED INSTRUC.
K896964 · Medtronic Vascular · Jun 1990
VASCULAR GRAFT PACKAGE (SHELF-LIFE EXTENSION)
K894732 · Medtronic Vascular · Oct 1989