510(k) K211610

Fogarty Occlusion Catheter by Edwards Lifesciences, LLC — Product Code MJN

K211610 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "Fogarty Occlusion Catheter". The FDA issued a decision of Substantially Equivalent on February 14, 2022. The device falls under product code MJN (Catheter, Intravascular Occluding, Temporary), a Class II device regulated under 21 CFR 870.4450. Edwards Lifesciences, LLC has at least 10 other 510(k) clearances on record.