510(k) K163452

PICC Maximal Barrier Nursing Kit by Navilyst Medical, Inc. — Product Code LJS

K163452 is an FDA 510(k) premarket notification submitted by Navilyst Medical, Inc. for the device "PICC Maximal Barrier Nursing Kit". The FDA issued a decision of Substantially Equivalent (kit) on February 3, 2017. 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. Navilyst Medical, Inc. has at least 10 other 510(k) clearances on record.