510(k) K213550

HydroPICC 5F Dual Lumen Catheter by Access Vascular, Inc. — Product Code LJS

K213550 is an FDA 510(k) premarket notification submitted by Access Vascular, Inc. for the device "HydroPICC 5F Dual Lumen Catheter". The FDA issued a decision of Substantially Equivalent on May 4, 2022. 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. Access Vascular, Inc. has at least 8 other 510(k) clearances on record.