510(k) K220305

Syntheon LAA Exclusion System, Syntheon LAA Selection Guide by Syntheon — Product Code PZX

K220305 is an FDA 510(k) premarket notification submitted by Syntheon for the device "Syntheon LAA Exclusion System, Syntheon LAA Selection Guide". The FDA issued a decision of Substantially Equivalent on October 28, 2022. The device falls under product code PZX (Left Atrial Appendage Clip, Implantable), a Class II device regulated under 21 CFR 878.4300. Syntheon has at least 2 other 510(k) clearances on record.