510(k) K053345

PRO-LINE CT POWER INJECTABLE CVC, MODELS CTLINES5S, CTLINE6D by Medcomp — Product Code LJS

K053345 is an FDA 510(k) premarket notification submitted by Medcomp for the device "PRO-LINE CT POWER INJECTABLE CVC, MODELS CTLINES5S, CTLINE6D". The FDA issued a decision of Substantially Equivalent on March 17, 2006. 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.