K243860
- 510(k) number
- K243860
- Device name
- AtriClip PRO-Mini LAA Exclusion System (PROM)
- Applicant
- AtriCure, Inc. OH · US
- Product code
- PZX — Left Atrial Appendage Clip, Implantable
- Decision date
- 2025-01-15
- Date received
- 2024-12-16
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K243860.pdf
Official FDA record: K243860
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.