510(k) K910315

PICC INSERTION KIT/P.I.C. & PICC EXCHANG KIT/P.E.K by Sorex Medical — Product Code LJS

K910315 is an FDA 510(k) premarket notification submitted by Sorex Medical for the device "PICC INSERTION KIT/P.I.C. & PICC EXCHANG KIT/P.E.K". The FDA issued a decision of Substantially Equivalent (kit, denovo) on April 5, 1991. 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. Sorex Medical has at least 8 other 510(k) clearances on record.