FDA cleared the ACHM30 AtriClip FLEX-Mini LAA Exclusion System from AtriCure, Inc. on Oct 21, 2026 under K263319, a special 510(k). The device falls under product code PZX, Left Atrial Appendage Clip, Implantable, regulated at 21 CFR 878.4300 as a Class 2 device. The review panel was General, Plastic Surgery.
FDA logged the submission as received on Sep 21, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).
This is the only decision on file for AtriCure, Inc. in the last 12 months of the tracker.
Questions & Answers
What did FDA clear under K263319?
K263319 is the FDA 510(k) for ACHM30 AtriClip FLEX-Mini LAA Exclusion System, submitted by AtriCure, Inc.. FDA's decision date was Oct 21, 2026, under product code PZX (Left Atrial Appendage Clip, Implantable).
Who makes the ACHM30 AtriClip FLEX-Mini LAA Exclusion System?
AtriCure, Inc., based in Mason, OH, is the applicant of record for K263319.
How long did the K263319 review take?
FDA received the submission on Sep 21, 2026 and issued its decision on Oct 21, 2026, 30 days later.