510(k) K993442

VYGON LIFECATH-PICC (PUR) CATHETERS (SINGLE AND DOUBLE LUMEN 3FR, 4FR, 4.5FR, AND 5FR) by Vygon Corp. — Product Code LJS

K993442 is an FDA 510(k) premarket notification submitted by Vygon Corp. for the device "VYGON LIFECATH-PICC (PUR) CATHETERS (SINGLE AND DOUBLE LUMEN 3FR, 4FR, 4.5FR, AND 5FR)". The FDA issued a decision of Substantially Equivalent on August 3, 2000. 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. Vygon Corp. has at least 10 other 510(k) clearances on record.