Exel Huber Infusion Set Without Injection Site (Y)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K904685 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Exel Spinal Needles

  Class II

  FDA 510(k) K895771 Active Cleared 16 Feb 1990

• Exel Dental Needle

  Class I

  FDA 510(k) K861150 Active Cleared 11 Apr 1986

• Exel Huber Infusion Set Rotating Wing

  Class II

  FDA 510(k) K926119 Active Cleared 11 Aug 1993

• Exel Safelet Catheter

  Class II

  FDA 510(k) K895768 Active Cleared 16 Feb 1990

• Disposable Syringes and Hypodermic Needles

  Class II

  FDA 510(k) K861153 Active Cleared 23 Apr 1986

• Exel a-V Fistula Set

  Class II

  FDA 510(k) K903945 Active Cleared 20 Nov 1990

See all devices from Exel Intl. →

• What is the Exel Huber Infusion Set Without Injection Site (Y) used for?

  The Exel Huber Infusion Set Without Injection Site (Y) is designed for the intravascular administration of fluids or medications. It is classified as a Set, Administration, Intravascular and is intended for medical use in clinical settings.

• How is the Exel Huber Infusion Set Without Injection Site (Y) supplied?

  The device is supplied by Exel Intl. It is a single-use device that comes in a model designated as (Y). The specific packaging details and quantities per package are not specified in the available device data.

• What is the regulatory status of the Exel Huber Infusion Set Without Injection Site (Y)?

  The Exel Huber Infusion Set Without Injection Site (Y) received FDA 510(k) clearance on November 21, 1990, with product code FPA. It is classified as Class II - Special Controls and was determined to be substantially equivalent to predicate devices.

• Is the Exel Huber Infusion Set Without Injection Site (Y) sterile?

  The device data does not explicitly state whether the Exel Huber Infusion Set Without Injection Site (Y) is supplied sterile. However, as an intravascular administration device, it would typically be expected to be sterile for patient safety, though this specific detail is not confirmed in the provided information.