Cleared Traditional

K903964 - OCHSNER 50 BIFURCATION

K903964 is an FDA 510(k) clearance for OCHSNER 50 BIFURCATION, manufactured by Intervascular, Inc.. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Traditional 510(k) pathway after a 97-day FDA review.

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

FDA 510(k) Submission Details - K903964

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.

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 160
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K903964.
PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT
K905067 · Pioneering Technologies, Inc. · Mar 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
PTI ANASTOMARK(TM) CORONARY BYPASS GRAFT MARKERS
K901682 · Pioneering Technologies, Inc. · Jul 1990
PLASMA TFE VASCULAR PROSTHESIS MODIFIED INSTRUC.
K896964 · Medtronic Vascular · Jun 1990