Cleared Traditional

K880040 - VELEX WOVEN EXTERNAL VELOUR DACRON GRAFT

K880040 is an FDA 510(k) clearance for VELEX WOVEN EXTERNAL VELOUR DACRON GRAFT, manufactured by D-R Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K880040 · D-R Medical Systems, Inc. · Cardiovascular device
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Jun 1988
Decision
156d
Days
Class 2
Risk

K880040 is an FDA 510(k) clearance for the VELEX WOVEN EXTERNAL VELOUR DACRON GRAFT. 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 June 9, 1988 after a review of 156 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

FDA 510(k) Submission Details - K880040

510(k) Number K880040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1988
Decision Date June 09, 1988
Days to Decision 156 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 125d · This submission: 156d
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 162
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K880040.
PLASMA TFE VASCULAR PROSTHESIS (ALTER. PACKAGE)
K893459 · Medtronic Vascular · Sep 1989
TORAY VASCULAR PROSTHESIS
K884083 · Toray Industries (America), Inc. · Jan 1989
ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH.
K882289 · Aries Medical, Inc. · Dec 1988
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