Skip to content

Exel Huber Infusion Set

by Exel Intl. 510(k)

Active United States

510(k) K895770

Overview

The Exel Huber Infusion Set is a non-coring infusion set designed for intravenous administration. It is used to access implanted ports for the delivery of fluids or medications.

This device is latex-free and supplied in various configurations, including options with Y-injection sites and different needle gauges and lengths. It has received FDA 510k clearance as a traditional medical device.

AI-generated from registry data, 26 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK895770 Date19 Jul 1990ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-0640-2010 FDA Unclassified (pre-2012) initiated 23 Dec 2009

    Coring of port's septum, which may lead to: Decreased effectiveness of port, infection, necrosis, swelling, and embolization, which may result in Pulmonary Embolism, Limb ischemia, stroke, local extravasation of medication such as chemotherapy or other caustic material, may lead to local tissue necrosis, granulomas, failure to deliver therapy, need for additional surgery to replace implanted port

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

Other devices from Exel Intl.

See all devices from Exel Intl. →

Questions

  • What is the primary purpose of the Exel Huber Infusion Set?

    This device is specifically designed for intravenous administration, allowing clinicians to access implanted ports for the delivery of necessary fluids or medications to a patient.

  • Are there different configurations available for this infusion set?

    Yes, the Exel Huber Infusion Set is supplied in various configurations to meet clinical needs. This includes options with different needle gauges and lengths, as well as versions that feature Y-injection sites.

  • Is the Exel Huber Infusion Set made with latex?

    No, this device is manufactured to be latex-free, which helps reduce the risk of allergic reactions for patients who have sensitivities to latex materials.

  • What is the regulatory status of this device?

    The Exel Huber Infusion Set has received FDA 510k clearance as a traditional medical device, confirming it has been found substantially equivalent to other legally marketed devices.