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Vanguard Reprocessed Diagnostic Electrophysiology Catheter Accessory Cables

by Vanguard Medical Concepts, Inc.

510(k) K030005

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 NumberK030005 Date18 Mar 2003ClearedStatusActive

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  • Withdrawn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
DSA
Device Class
Class II
Regulation
21 CFR Part 870.2900
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

These devices are patient cables, transducers, and electrodes, including connectors, designed to serve as electrical interfaces. They function by connecting diagnostic electrophysiology catheters to recording or pacing consoles.

The device consists of a 4 to 7-foot hollow polymer shaft with connectors at both ends. It is supplied as a reprocessed medical device and has received FDA 510(k) clearance.

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Questions

AI-generated answers, 22 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 these accessory cables?

    These devices act as electrical interfaces designed to connect diagnostic electrophysiology catheters to recording or pacing consoles during clinical procedures.

  • What are the physical specifications of the cable?

    The device consists of a hollow polymer shaft that measures between 4 and 7 feet in length, featuring connectors at both ends to facilitate the required electrical interface.

  • How is this device supplied to the facility?

    This product is supplied as a reprocessed medical device, which has received FDA 510(k) clearance for use in clinical settings.