PeriBeam® Pericardial Membrane— 510(k) K240775

Substantially Equivalent

Tamabio

FDA 510(k) clearance K240775 for PeriBeam® Pericardial Membrane, Substantially Equivalent on 2025-04-18. Applicant: Tamabio.

Clearance details

Applicant: Tamabio
Product code: Code DXZ
Advisory panel: Cardiovascular
Date received: 2024-03-21
Decision date: 2025-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXZ

product code DXZ

Death: 19
Injury: 265
Total: 284

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.