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PFA Patch

by Peritec Biosciences, LLC

510(k) K041736

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 NumberK041736 Date13 Jan 2005ClearedStatusActive

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  • Withdrawn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
DXZ
Device Class
Class II
Regulation
21 CFR Part 870.3470
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

The PFA Patch is a vascular patch or intracardiac pledget, classified under 21 CFR 870.3470. Constructed from expanded polytetrafluoroethylene (ePTFE) and polypropylene, it is designed to reinforce or repair vascular structures, including blood vessels and intracardiac tissues, by providing mechanical support during surgical procedures.

Supplied as a single-use, non-sterile device, the PFA Patch is intended for use in sterile surgical environments. It is regulated under FDA 510(k) clearance (K041736) and falls under regulatory class II. The patch is available in multiple sizes, as referenced by its FEI numbers, and must be sterilized prior to use. No additional regulatory approvals beyond the stated 510(k) clearance are implied.

Questions

AI-generated answers, 19 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 materials is the PFA Patch made from and how does this affect its use in surgery?

    The PFA Patch is constructed from expanded polytetrafluoroethylene (ePTFE) and polypropylene, which provide durability and mechanical support for reinforcing or repairing vascular structures and intracardiac tissues. These materials are biocompatible and designed to withstand the demands of surgical environments, ensuring stability during procedures like vascular grafting or intracardiac repairs.

  • Is the PFA Patch intended for single-use or can it be reused after sterilization?

    The PFA Patch is explicitly labeled as a single-use device, though it must be sterilized prior to use in a sterile surgical environment. Reuse is not recommended or supported by the manufacturer, even after sterilization, as this could compromise its structural integrity or sterility.

  • What sizes are available for the PFA Patch, and how do I identify the correct size for my procedure?

    The PFA Patch comes in multiple sizes, each referenced by a unique FEI number (e.g., 2183620, 1526611, etc.). These sizes correspond to specific dimensions tailored for vascular or intracardiac applications. Consult the manufacturer’s documentation or surgical guidelines to match the FEI number with the anatomical requirements of your patient’s procedure.

  • How should the PFA Patch be stored before use, and what precautions should be taken?

    The PFA Patch is supplied in a non-sterile state and must be sterilized before use in a sterile surgical environment. Storage should follow the manufacturer’s instructions to maintain its integrity, typically in a clean, dry place away from direct sunlight or extreme temperatures until sterilization is performed.

  • What regulatory pathway does the PFA Patch follow, and how does this impact its availability?

    The PFA Patch is regulated under the FDA’s 510(k) clearance process (K041736) and classified as a Class II device under 21 CFR 870.3470. This means it has undergone a premarket review to demonstrate substantial equivalence to a legally marketed predicate device. Availability is limited to approved channels and requires adherence to FDA compliance standards.