510(k) K190559

SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports by AngioDynamics, Inc. — Product Code LJT

K190559 is an FDA 510(k) premarket notification submitted by AngioDynamics, Inc. for the device "SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports". The FDA issued a decision of Substantially Equivalent on May 22, 2020. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. AngioDynamics, Inc. has at least 10 other 510(k) clearances on record.