510(k) K192246

Biowy PICC Catheter S Kit by Biowy Corporation — Product Code LJS

K192246 is an FDA 510(k) premarket notification submitted by Biowy Corporation for the device "Biowy PICC Catheter S Kit". The FDA issued a decision of Substantially Equivalent on April 30, 2020. 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. Biowy Corporation has at least 2 other 510(k) clearances on record.