Cleared Traditional

K884083 - TORAY VASCULAR PROSTHESIS

K884083 is the FDA 510(k) clearance for TORAY VASCULAR PROSTHESIS by Toray Industries (America), Inc.. It is a Class 2 Cardiovascular device (product code DSY) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K884083 · Toray Industries (America), Inc. · Cardiovascular device
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Jan 1989
Decision
107d
Days
Class 2
Risk

K884083 is an FDA 510(k) clearance for the TORAY VASCULAR PROSTHESIS. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Toray Industries (America), Inc. (Houston, US). The FDA issued a Cleared decision on January 12, 1989 after a review of 107 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 Toray Industries (America), Inc. devices

Submission Details

510(k) Number K884083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1988
Decision Date January 12, 1989
Days to Decision 107 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 125d · This submission: 107d
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 97
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K884083.
PLASMA TFE VASCULAR PROSTHESIS MODIFIED INSTRUC.
K896964 · Medtronic Vascular · Jun 1990
VASCULAR GRAFT PACKAGE (SHELF-LIFE EXTENSION)
K894732 · Medtronic Vascular · Oct 1989
PLASMA TFE VASCULAR PROSTHESIS (ALTER. PACKAGE)
K893459 · Medtronic Vascular · Sep 1989
MEADOX INTRA-AORTIC GRAFT
K881283 · Meadox Medicals, Div. Boston Scientific Corp. · May 1988
GORE-TEX VASCULAR GRAFT
K880167 · W.L. Gore & Associates, Inc. · May 1988
CORONARY ARTERY BYPASS GRAFT (CABG) MARKER
K871110 · Edward Weck, Inc. · Aug 1987