510(k) K831587

TEMP. REPAIR KIT-DUAL LUMEN CATHETER by Norton Performance Plastics Corp. — Product Code LJS

K831587 is an FDA 510(k) premarket notification submitted by Norton Performance Plastics Corp. for the device "TEMP. REPAIR KIT-DUAL LUMEN CATHETER". The FDA issued a decision of Substantially Equivalent on October 19, 1983. 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. Norton Performance Plastics Corp. has at least 10 other 510(k) clearances on record.