510(k) K234125
K234125 is an FDA 510(k) premarket notification submitted by AtriCure, Inc. for the device "AtriClip FLEX-Mini LAA Exclusion System (ACHM)". The FDA issued a decision of Substantially Equivalent on July 29, 2024. The device falls under product code PZX (Left Atrial Appendage Clip, Implantable), a Class II device regulated under 21 CFR 878.4300. AtriCure, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 29, 2024
- Date Received
- December 28, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Left Atrial Appendage Clip, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4300
- Review Panel
- CV
- Submission Type
Intended to occlude the left atrial appendage.