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UNICATH A

by Xre Corp. 510(k)

Active United States

510(k) K892849

Overview

The UNICATH A is an angiographic x-ray system intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This device is classified under product code IZI and is manufactured by Xre Corp.

The UNICATH A received FDA 510(k) clearance on August 9, 1989, with K-number K892849, and is classified as a Class II device. It is regulated under regulation number 892.1600 and is intended for use in radiology settings. The device is supplied with various model numbers and reference codes as specified in the manufacturer's documentation.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK892849 Date9 Aug 1989ClearedStatusActive

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

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
IZI
Device Class
Class II
Regulation
21 CFR Part 892.1600
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the UNICATH A used for?

    The UNICATH A is an angiographic x-ray system designed for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium, intended for use in radiology settings.

  • How is the UNICATH A supplied?

    The UNICATH A is supplied with various model numbers and reference codes as specified in the manufacturer's documentation. The device is manufactured by Xre Corp. and distributed with specific model configurations.

  • What is the regulatory status of the UNICATH A?

    The UNICATH A received FDA 510(k) clearance on August 9, 1989, with K-number K892849. It is classified as a Class II device under product code IZI and regulated under number 892.1600.

  • What are the specifications of the UNICATH A?

    The UNICATH A is a Class II device that is substantially equivalent to other angiographic x-ray systems. It is manufactured by Xre Corp. and intended for radiology settings, with various model numbers and reference codes available as per manufacturer documentation.