510(k) K260080

Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler by Medical Components, Inc. — Product Code LJS

K260080 is an FDA 510(k) premarket notification submitted by Medical Components, Inc. for the device "Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler". The FDA issued a decision of Substantially Equivalent on Oct 9, 2026. 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. Medical Components, Inc. has 63 other 510(k) clearances on record.