510(k) K181904

5 FR Dual Lumen Piper PICC by Piper Access, LLC — Product Code LJS

K181904 is an FDA 510(k) premarket notification submitted by Piper Access, LLC for the device "5 FR Dual Lumen Piper PICC". The FDA issued a decision of Substantially Equivalent on September 25, 2018. The device falls under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days), a Class II device regulated under 21 CFR 880.5970. Piper Access, LLC has at least 2 other 510(k) clearances on record.