FDA 510(k)

PeriBeam® Pericardial Membrane

K-Number: K240775 · 2025-04-18

Decision Date2025-04-18

Product CodeDXZ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: DXZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200955Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid PatchVascutek, Ltd.K162506PhotoFix Decellularized Bovine PericardiumCryolife, Inc.K162579VascuCelAdmedus Regen Pty, Ltd.K152127CorMatrix TykeCormatrix Cardiovascular, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.