510(k) K150527

Xcela Power Injectable PICC by Navilyst Medical, Inc. — Product Code LJS

K150527 is an FDA 510(k) premarket notification submitted by Navilyst Medical, Inc. for the device "Xcela Power Injectable PICC". The FDA issued a decision of Substantially Equivalent on March 31, 2015. 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.