Cleared Traditional

High Pressure Tubing

K244038 · Shandong Int Medical Instruments Co., Ltd. · General Hospital

Sep 2025

Decision

249d

Days

Class 2

Risk

About This 510(k) Submission

K244038 is an FDA 510(k) clearance for the High Pressure Tubing, a Injector And Syringe, Angiographic (Class II — Special Controls, product code DXT), submitted by Shandong Int Medical Instruments Co., Ltd. (Shandong, CN). The FDA issued a Cleared decision on September 5, 2025, 249 days after receiving the submission on December 30, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number	K244038 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 30, 2024
Decision Date	September 05, 2025
Days to Decision	249 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF