Class Class II
AtriClip FLEX-Mini LAA Exclusion System (ACHM) (K234125)
Description
AtriClip FLEX-Mini LAA Exclusion System (ACHM) by AtriCure, Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK234125
Clearance Date2024-07-29
Clearance TypeTraditional
Product CodePZX
Regulation Number878.4300
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K234125
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. AtriClip FLEX-Mini LAA Exclusion System (ACHM) (K234125) cites 0 predicate devices and is itself cited by 1 later device.
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243860 | AtriClip PRO-Mini LAA Exclusion System (PROM) | AtriCure, Inc. | 2025 |
Trace the full predicate network for K234125
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.