510(k) K230668

Disposable High-pressure Extension Lines by Precision Medical Plastics , Ltd. — Product Code DXT

K230668 is an FDA 510(k) premarket notification submitted by Precision Medical Plastics , Ltd. for the device "Disposable High-pressure Extension Lines". The FDA issued a decision of Substantially Equivalent on June 14, 2024. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650.