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Ac 3 Lumen Central Venous Access Kit With Arrowg+ard Antimicrobial Surface

by Arrow Intl., Inc.

510(k) K032962

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 · Special NumberK032962 Date29 Oct 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  • Withdrawn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
FOZ
Device Class
Class II
Regulation
21 CFR Part 880.5200
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Ac 3 Lumen Central Venous Access Kit is a medical device designed to permit venous access and catheter introduction to the central circulation. It features an Arrowg+ard antimicrobial surface intended to provide protection against access device-related infections.

This device is used in clinical settings for patients requiring intravenous therapy. It is supplied as a kit and is not made with natural rubber latex. The device has received FDA 510k clearance.

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