Cleared Traditional

PeriBeam? Pericardial Membrane

K240775 · Tamabio · Cardiovascular

Apr 2025

Decision

393d

Days

Class 2

Risk

About This 510(k) Submission

K240775 is an FDA 510(k) clearance for the PeriBeam? Pericardial Membrane, a Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (Class II — Special Controls, product code DXZ), submitted by Tamabio (Tokyo, JP). The FDA issued a Cleared decision on April 18, 2025, 393 days after receiving the submission on March 21, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3470.

Submission Details

510(k) Number	K240775 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 21, 2024
Decision Date	April 18, 2025
Days to Decision	393 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF