Cleared Traditional

High Pressure Tubing

K232388 · Ningbo Dizegens Medical Science Co.,Ltd · General Hospital

Nov 2023

Decision

104d

Days

Class 2

Risk

About This 510(k) Submission

K232388 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 Ningbo Dizegens Medical Science Co.,Ltd (Ningbo, CN). The FDA issued a Cleared decision on November 21, 2023, 104 days after receiving the submission on August 9, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number	K232388 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 09, 2023
Decision Date	November 21, 2023
Days to Decision	104 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF