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DeBakey Vasculour-D Prostheses

by Usci, Div. C.R. Bard, Inc.

510(k) K770235

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 NumberK770235 Date24 Feb 1977ClearedStatusActive

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  • Withdrawn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, 26 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 vascular prosthesis with a diameter of 6mm or greater, classified as a prosthesis, vascular graft. It is a substantially equivalent device cleared through the traditional 510(k) pathway.

Manufactured by Usci, Division of C.R. Bard, Inc., the device received FDA 510(k) clearance under K770235 on February 24, 1977. It is supplied as a vascular graft for use in cardiovascular applications, with product code DSY and regulation number 870.3450.

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Questions

AI-generated answers, 26 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 DEBAKEY VASCULOUR-D PROSTHESES used for?

    This device is a vascular prosthesis designed for use in cardiovascular applications, specifically as a vascular graft with a diameter of 6mm or greater to replace or bypass diseased blood vessels.

  • How is the DEBAKEY VASCULOUR-D PROSTHESES supplied and is it sterile?

    The device is supplied as a vascular graft for cardiovascular use; while the data does not explicitly state sterility, its classification as a prosthesis and FDA 510(k) clearance imply it is intended for sterile surgical implantation.

  • Is the DEBAKEY VASCULOUR-D PROSTHESES a single-use or reusable device?

    As a vascular prosthesis implanted surgically, the DEBAKEY VASCULOUR-D PROSTHESES is intended for single-use implantation and is not designed for removal, reprocessing, or reuse after implantation.

  • What sizes or models are available for the DEBAKEY VASCULOUR-D PROSTHESES?

    The device is specified as having a diameter of 6mm or greater; no further size variations or model numbers are provided in the data beyond this minimum diameter threshold.

  • What regulatory pathway was used for the DEBAKEY VASCULOUR-D PROSTHESES?

    The device received FDA 510(k) clearance through the traditional pathway under submission K770235, indicating it was found substantially equivalent to a legally marketed predicate device.