K252917
- 510(k) number
- K252917
- Device name
- ATLAAS (Atraumatic Left Atrial Appendage System) (AD)
- Applicant
- Genesee Biomedical, Inc. CO · US
- Product code
- PZX — Left Atrial Appendage Clip, Implantable
- Decision date
- 2026-05-22
- Date received
- 2025-09-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K252917.pdf
Official FDA record: K252917
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.