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Vascular Catheter Wireguides

by Stanco Medical, Inc.

510(k) K802260

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 NumberK802260 Date10 Oct 1980ClearedStatusActive

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  • Withdrawn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
DQX
Device Class
Class II
Regulation
21 CFR Part 870.1330
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

The Vascular Catheter Wireguide is a cardiovascular device designed to assist in the placement and positioning of catheters within the vascular system. It functions as a guide wire to facilitate navigation through blood vessels during clinical procedures.

This device is identified by FDA 510(k) number K802260 and is classified as a class 2 medical device. It has received FDA 510(k) clearance under the product code DQX.

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Questions

AI-generated answers, 27 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 primary function of the Stanco Medical Vascular Catheter Wireguide?

    This device is designed to assist clinicians in the placement and positioning of catheters within the vascular system. It acts as a guide wire to facilitate navigation through blood vessels during cardiovascular clinical procedures.

  • What is the regulatory status of this device?

    The Vascular Catheter Wireguide is a class 2 medical device that has received FDA 510(k) clearance under the product code DQX. It is identified by the FDA 510(k) number K802260, which confirms it has been found substantially equivalent to predicate devices.

  • Which advisory committee oversees this device category?

    This device falls under the oversight of the Cardiovascular advisory committee. This classification reflects the intended use of the wireguide for navigating the vascular system during medical procedures.