510(k) K151620

Firefly Peritoneal Dialysis Connector Disinfection System by Puracath Medical, Inc. — Product Code KDJ

K151620 is an FDA 510(k) premarket notification submitted by Puracath Medical, Inc. for the device "Firefly Peritoneal Dialysis Connector Disinfection System". The FDA issued a decision of Substantially Equivalent on January 20, 2016. The device falls under product code KDJ (Set, Administration, For Peritoneal Dialysis, Disposable), a Class II device regulated under 21 CFR 876.5630. Puracath Medical, Inc. has at least 2 other 510(k) clearances on record.