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Angiography Injector

by Shandong Int Medical Instruments Co., Ltd.

510(k) K242143

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 NumberK242143 Date23 Dec 2024ClearedStatusActive

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  • Withdrawn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
DXT
Device Class
Class II
Regulation
21 CFR Part 870.1650
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

The Angiography Injector is a medical device used in cardiovascular applications. It is designed to inject contrast media into the body during angiography procedures. The device is classified as a Class 2 device with the product code DXT. The Angiography Injector is substantially equivalent to other devices on the market.

The Angiography Injector is supplied by Shandong Int Medical Instruments Co., Ltd. and has received FDA 510(k) clearance, indicated by the clearance number K242143. The device has undergone biocompatibility testing in accordance with ISO 10993-1. The Angiography Injector is intended for use in a general hospital setting and is regulated under the regulation number 870.1650.

Other devices from Shandong Int Medical Instruments Co., Ltd.

Questions

AI-generated answers, 25 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 Angiography Injector used for?

    The Angiography Injector is used to inject contrast media into the body during angiography procedures in cardiovascular applications.

  • Has the Angiography Injector undergone biocompatibility testing?

    Yes, the Angiography Injector has undergone biocompatibility testing in accordance with ISO 10993-1.

  • What is the regulatory classification of the Angiography Injector?

    The Angiography Injector is classified as a Class 2 device with the product code DXT and is regulated under the regulation number 870.1650.