510(k) K160084

Swan Ganz Catheters by Edwards Lifesciences, LLC — Product Code DYG

K160084 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "Swan Ganz Catheters". The FDA issued a decision of Substantially Equivalent on May 3, 2016. The device falls under product code DYG (Catheter, Flow Directed), a Class II device regulated under 21 CFR 870.1240. Edwards Lifesciences, LLC has at least 10 other 510(k) clearances on record.