510(k) K880571

CATH-TECH PORT IMPLANTABLE VASCULAR ACCESS SYSTEM by Catheter Technology Corp. — Product Code LJT

K880571 is an FDA 510(k) premarket notification submitted by Catheter Technology Corp. for the device "CATH-TECH PORT IMPLANTABLE VASCULAR ACCESS SYSTEM". The FDA issued a decision of Substantially Equivalent on March 4, 1988. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Catheter Technology Corp. has at least 10 other 510(k) clearances on record.