Class Class II
AtriClip PRO-Mini LAA Exclusion System (PROM) (K243860)
Description
AtriClip PRO-Mini LAA Exclusion System (PROM) by AtriCure, Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243860
Clearance Date2025-01-15
Clearance TypeSpecial
Product CodePZX
Regulation Number878.4300
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243860
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 PRO-Mini LAA Exclusion System (PROM) (K243860) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K234125 | AtriClip FLEX-Mini LAA Exclusion System (ACHM) | AtriCure, Inc. | 2024 |
| K172742 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgr... | AtriCure, Inc. | 2017 |
| K160454 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgr... | AtriCure, Inc. | 2016 |
Trace the full predicate network for K243860
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.