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Intravascular Extension Sets and Accessories

by Baxter Healthcare Corporation 2 variants

510(k) K242339

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK242339 Date28 Feb 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 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  • Withdrawn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
FPA
Device Class
Class II
Regulation
21 CFR Part 880.5440
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 Intravascular Extension Sets and Accessories are a type of administration set used to increase the length of a primary infusion set. They are available in a variety of lengths and configurations. The device is classified as a Set, Administration, Intravascular with product code FPA. It is a Class II device with special controls. The device is used in infusion therapies and technologies.

The Intravascular Extension Sets and Accessories are supplied by Baxter Healthcare Corporation. The device has received FDA 510(k) clearance, with clearance type Traditional and k number K242339. The device is intended for use in a general hospital setting. It is available in various sizes and configurations, but specific storage and sterility information is not provided. The device has been assigned a product code of FPA and is classified as a Class II device with special controls.

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