510(k) K152409

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

K152409 is an FDA 510(k) premarket notification submitted by Navilyst Medical, Inc. for the device "Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC". The FDA issued a decision of Substantially Equivalent on September 24, 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.