510(k) K221528

Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter by Edwards Lifesciences, LLC — Product Code DXF

K221528 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter". The FDA issued a decision of Substantially Equivalent on August 22, 2022. The device falls under product code DXF (Catheter, Septostomy), a Class II device regulated under 21 CFR 870.5175. Edwards Lifesciences, LLC has at least 10 other 510(k) clearances on record.