Cleared Traditional

Disposable High-pressure Extension Lines

K230668 · Precision Medical Plastics , Ltd. · General Hospital

Jun 2024

Decision

462d

Days

Class 2

Risk

About This 510(k) Submission

K230668 is an FDA 510(k) clearance for the Disposable High-pressure Extension Lines, a Injector And Syringe, Angiographic (Class II — Special Controls, product code DXT), submitted by Precision Medical Plastics , Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 14, 2024, 462 days after receiving the submission on March 10, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number	K230668 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 10, 2023
Decision Date	June 14, 2024
Days to Decision	462 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement