K240775
- 510(k) number
- K240775
- Device name
- PeriBeam® Pericardial Membrane
- Applicant
- Tamabio JP
- Product code
- DXZ — Patch, Pledget And Intracardiac, Petp, Ptfe, Polypro
- Decision date
- 2025-04-18
- Date received
- 2024-03-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K240775.pdf
Official FDA record: K240775
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.