FDA 510(k)

PeriBeam® Pericardial Membrane

N.º K: K240775 · 2025-04-18

SolicitanteTamabio

Fecha de decisión2025-04-18

Código de productoDXZ

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

PeriBeam® Pericardial Membrane is the device name listed in this FDA 510(k) record. The listed applicant is Tamabio. It received FDA 510(k) clearance on 2025-04-18 under 510(k) number K240775. The device is classified under product code DXZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the PeriBeam® Pericardial Membrane?

PeriBeam® Pericardial Membrane is a medical device that received FDA 510(k) clearance on 2025-04-18. The listed applicant is Tamabio. The 510(k) number is K240775.

When did PeriBeam® Pericardial Membrane receive FDA 510(k) clearance?

PeriBeam® Pericardial Membrane received FDA 510(k) clearance on 2025-04-18, under 510(k) number K240775.

Who is the listed applicant for PeriBeam® Pericardial Membrane?

The FDA 510(k) record lists Tamabio as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PeriBeam® Pericardial Membrane?

The FDA product code for PeriBeam® Pericardial Membrane is DXZ.

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Fuente oficial

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