510(k) K081904

PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY) by Medcomp — Product Code LJS

K081904 is an FDA 510(k) premarket notification submitted by Medcomp for the device "PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY)". The FDA issued a decision of Substantially Equivalent on September 23, 2008. 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. Medcomp has at least 10 other 510(k) clearances on record.