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FDA 510(k)

PeriBeam® Pericardial Membrane

K-Number: K240775 · 2025-04-18

ApplicantTamabio
Decision Date2025-04-18
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PeriBeam® Pericardial Membrane is a medical device manufactured by Tamabio. It received FDA 510(k) clearance on 2025-04-18 under approval 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. It is manufactured by Tamabio. The 510(k) number is K240775.

When was PeriBeam® Pericardial Membrane approved by the FDA?

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

What company makes PeriBeam® Pericardial Membrane?

PeriBeam® Pericardial Membrane is manufactured by Tamabio.

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

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

Related Devices (Code: DXZ)

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

Official Source

View on FDA Database →

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

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