510(k) K061936

KENDALL ARGYLE NEONATAL/PEDIATRIC PICC, MODEL 43311 by The Kendall Company — Product Code LJS

K061936 is an FDA 510(k) premarket notification submitted by The Kendall Company for the device "KENDALL ARGYLE NEONATAL/PEDIATRIC PICC, MODEL 43311". The FDA issued a decision of Substantially Equivalent on August 9, 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. The Kendall Company has at least 10 other 510(k) clearances on record.