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Angiourography Kit

by Mallinckrodt Critical Care

510(k) K822159

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 NumberK822159 Date3 Nov 1982ClearedStatusActive

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  • Withdrawn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
FMF
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

An angiourography kit is a syringe, piston device used for medical procedures. It is classified under product code FMF and falls under the General Hospital medical specialty.

The device was cleared by the FDA through the 510(k) process with decision date November 3, 1982, and is supplied as a substantially equivalent device. It is intended for use in general hospital settings.

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Questions

AI-generated answers, 27 Sep 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 angiourography kit used for?

    The angiourography kit is a syringe and piston device intended for use in medical procedures within general hospital settings, as specified in its FDA 510(k) clearance.

  • How is the angiourography kit supplied and is it reusable?

    The device is supplied as a syringe and piston system; however, the provided data does not specify whether it is single-use or reusable, so reuse status cannot be determined from the available information.

  • What regulatory pathway was used for the angiourography kit?

    The angiourography kit received FDA clearance through the traditional 510(k) process, with a decision date of November 3, 1982, and was found substantially equivalent to a predicate device.