Cleared Traditional

Angiography Injector

K242143 · Shandong Int Medical Instruments Co., Ltd. · General Hospital

Dec 2024

Decision

154d

Days

Class 2

Risk

About This 510(k) Submission

K242143 is an FDA 510(k) clearance for the Angiography Injector, a Injector And Syringe, Angiographic (Class II — Special Controls, product code DXT), submitted by Shandong Int Medical Instruments Co., Ltd. (Rizhao, CN). The FDA issued a Cleared decision on December 23, 2024, 154 days after receiving the submission on July 22, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number	K242143 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 22, 2024
Decision Date	December 23, 2024
Days to Decision	154 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF