Cleared Traditional

EXTENDED PACKAGE DATING ON VELEX WOVEN GRAFTS (K890597) - FDA 510(k) Clearance

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

K890597 · D-R Medical Systems, Inc. · Cardiovascular device
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Sep 1989
Decision
243d
Days
Class 2
Risk

K890597 is an FDA 510(k) clearance for the EXTENDED PACKAGE DATING ON VELEX WOVEN GRAFTS. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by D-R Medical Systems, Inc. (Northvale, US). The FDA issued a Cleared decision on September 26, 1989 after a review of 243 days - an extended review 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: 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 D-R Medical Systems, Inc. devices

Submission Details

510(k) Number K890597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1989
Decision Date September 26, 1989
Days to Decision 243 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 125d · This submission: 243d
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 58
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K890597.
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
PLASMA TFE VASCULAR PROSTHESIS (ALTER. PACKAGE)
K893459 · Medtronic Vascular · Sep 1989
GORE-TEX VASCULAR GRAFT
K880167 · W.L. Gore & Associates, Inc. · May 1988
CORONARY ARTERY BYPASS GRAFT (CABG) MARKER
K871110 · Edward Weck, Inc. · Aug 1987