510(k) K181208

Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter by Vygon USA — Product Code PND

K181208 is an FDA 510(k) premarket notification submitted by Vygon USA for the device "Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter". The FDA issued a decision of Substantially Equivalent on November 2, 2018. The device falls under product code PND (Midline Catheter), a Class II device regulated under 21 CFR 880.5200. Vygon USA has at least 3 other 510(k) clearances on record.