510(k) K093309

PRO-LINE CT (BASIC TRAY) MODEL MR28036101 by Medcomp ( Medical Components) — Product Code LJS

K093309 is an FDA 510(k) premarket notification submitted by Medcomp ( Medical Components) for the device "PRO-LINE CT (BASIC TRAY) MODEL MR28036101". The FDA issued a decision of Substantially Equivalent on November 24, 2009. 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 ( Medical Components) has at least 6 other 510(k) clearances on record.