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MR Extension Set (001)

by University of Michigan

510(k) K964968

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 NumberK964968 Date27 Feb 1997ClearedStatusActive

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  • Withdrawn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
FPA
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The MR Extension Set (001) is a Set, Administration, Intravascular device (product code FPA), designed to facilitate intravenous fluid administration in magnetic resonance (MR) imaging environments. It includes components such as tubing, connectors, a drip chamber, and a spike for fluid delivery, ensuring compatibility with MR-compatible infusion systems while maintaining sterility and functionality during imaging procedures.

This device is supplied as a sterile, single-use administration set intended for intravenous use. It is intended for use in MR-compatible settings, where its components are designed to avoid interference with imaging while delivering fluids safely. The set is regulated under FDA 510(k) clearance (K964968) and classified as Class II under Special Controls, with no third-party manufacturing involvement. Storage and handling follow standard sterile medical device protocols.

Other devices from University of Michigan

Questions

AI-generated answers, 1 Oct 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 MR Extension Set (001) used for?

    The MR Extension Set (001) is designed specifically for intravenous fluid administration in magnetic resonance (MR) imaging environments. Its components, including tubing, connectors, a drip chamber, and spike, ensure compatibility with MR-compatible infusion systems while preventing interference with imaging procedures. This makes it ideal for patients requiring fluids during MR scans.

  • Is the MR Extension Set (001) sterile and single-use?

    Yes, the MR Extension Set (001) is supplied as a sterile, single-use administration set. Sterility is maintained to ensure patient safety during intravenous use, and its single-use design prevents contamination or cross-infection between patients.

  • How does the MR Extension Set (001) avoid interfering with MR imaging?

    The set is engineered with materials and components that are MR-compatible, meaning they do not produce artifacts or disrupt the magnetic field during imaging. This ensures clear, uninterrupted MR scans while fluids are administered safely to the patient.

  • What regulatory approval does the MR Extension Set (001) hold?

    The MR Extension Set (001) holds FDA 510(k) clearance under the reference number K964968. It is classified as a Class II medical device under Special Controls, with no third-party manufacturing involved, ensuring compliance with U.S. regulatory standards for intravenous administration sets.

  • How should the MR Extension Set (001) be stored and handled?

    The set should be stored following standard sterile medical device protocols to maintain its integrity. This includes keeping it in a clean, dry environment, away from direct sunlight or extreme temperatures, and ensuring the packaging remains unopened until immediate use. Proper handling minimizes the risk of contamination and ensures sterility.