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Peri-Guard Pericardium

by Bio-Vascular, Inc.

510(k) K961811

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK961811 Date13 Jun 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FTM
Device Class
Class II
Regulation
21 CFR Part 878.3300
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

PERI-GUARD PERICARDIUM is a surgical mesh prosthesis derived from bovine pericardium. It is cross-linked with glutaraldehyde and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25°C (68-77°F). The device is chemically sterilized using ethanol and propylene oxide.

It is supplied as a repair patch for use as a prosthesis in pericardial closure and soft tissue deficiencies, including defects of the thoracic wall, intracardiac and great vessel repair. The device is regulated under FDA 510(k) clearance (K961811) and classified as a Class II surgical mesh. It is intended for use in general and plastic surgery settings.

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Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is PERI-GUARD PERICARDIUM used for?

    PERI-GUARD PERICARDIUM is used as a surgical mesh prosthesis for pericardial closure and repair of soft tissue deficiencies, including defects in the thoracic wall, intracardiac structures, and great vessels, based on its bovine pericardium origin and chemical treatment for structural integrity.

  • How is PERI-GUARD PERICARDIUM supplied and sterilized?

    PERI-GUARD PERICARDIUM is supplied as a repair patch and is chemically sterilized using ethanol and propylene oxide, ensuring microbial reduction while preserving the cross-linked bovine pericardium matrix for implantation.

  • Is PERI-GUARD PERICARDIUM intended for single-use or reuse?

    PERI-GUARD PERICARDIUM is intended for single-use only, as it is a sterile implantable prosthesis designed for one-time surgical implantation and not designed, validated, or labeled for reprocessing or reuse.

  • What materials and treatments are used in PERI-GUARD PERICARDIUM?

    PERI-GUARD PERICARDIUM is made from bovine pericardium that is cross-linked with glutaraldehyde and treated with 1 molar sodium hydroxide for at least 60 minutes at 20-25°C, followed by chemical sterilization with ethanol and propylene oxide to enhance durability and reduce antigenicity.

  • What regulatory pathway was used for PERI-GUARD PERICARDIUM?

    PERI-GUARD PERICARDIUM received market authorization through the FDA 510(k) clearance process under submission K961811, demonstrating substantial equivalence to a predicate device and is classified as a Class II surgical mesh under regulation number 878.3300.