Skip to content

Velex Woven Dacron Low Porsity Vascular Graft

by D-R Medical Systems, Inc.

510(k) K880041

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK880041 Date10 Jun 1988ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DSY
Device Class
Class II
Regulation
21 CFR Part 870.3450
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a prosthesis, vascular graft, of 6mm and greater diameter. It is a woven Dacron vascular graft with low porosity.

It was cleared via the FDA 510(k) process under K880041, with a decision date of 1988-06-10. The device is classified under regulation number 870.3450 and product code DSY, and is intended for cardiovascular use.

Other devices from D-R Medical Systems, Inc.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the VELEX Woven Dacron Low Porosity Vascular Graft used for?

    The device is a vascular graft prosthesis intended for cardiovascular use, specifically designed for vessels with a diameter of 6mm or greater, as indicated by its classification under regulation number 870.3450 and product code DSY for prosthesis, vascular graft.

  • How was the VELEX Woven Dacron Low Porosity Vascular Graft cleared for market?

    The device was cleared through the FDA 510(k) process under submission K880041, with a decision date of June 10, 1988, and was determined to be substantially equivalent to a predicate device.

  • What sizes or diameters is the VELEX Woven Dacron Low Porosity Vascular Graft available in?

    The device is available in diameters of 6mm and greater, as specified in the description stating it is a prosthesis, vascular graft, of 6mm and greater diameter.

  • What material is the VELEX Woven Dacron Low Porosity Vascular Graft made from?

    The graft is constructed from woven Dacron with low porosity, as explicitly stated in the device name and description.

  • Who manufactures the VELEX Woven Dacron Low Porosity Vascular Graft?

    The device is manufactured by D-R Medical Systems, Inc., located at 252 Livingston St., Northvale, NJ 07647, as indicated in the manufacturer and address fields.