510(k) K162088

Ecomed Disposable Angiographic Syringes by Ecomed Solutions, LLC — Product Code DXT

K162088 is an FDA 510(k) premarket notification submitted by Ecomed Solutions, LLC for the device "Ecomed Disposable Angiographic Syringes". The FDA issued a decision of Substantially Equivalent on January 27, 2017. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Ecomed Solutions, LLC has at least 2 other 510(k) clearances on record.