Skip to content

Macropore Cardio-Wrap (TS)

by Macropore Biosurgery, Inc.

510(k) K031785

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK031785 Date4 Sep 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
OMH
Device Class
Class II
Regulation
21 CFR Part 870.3470
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Macropore Cardio-Wrap (TS) is a resorbable pericardial patch designed to facilitate revision surgeries. Classified as a pericardial patch under FDA code K031785, it is intended for use as a pericardium replacement in patients who may require re-operation within six months. Constructed from poly lactic acid (PLA), this sheet-form implant is malleable and can be customized to the desired shape and size using scissors or the Macropore Power Pen.

Supplied as a sterile, single-use device, the Macropore Cardio-Wrap (TS) is intended for surgical use in cardiovascular procedures. It falls under FDA Class II (device class 2) and has received a Traditional 510(k) clearance (K031785) under the regulation number 870.3470. The device is not MRI-safe and must be handled with sterile techniques. Storage and handling instructions are specified in the accompanying documentation.

Other devices from Macropore Biosurgery, Inc.

See all devices from Macropore Biosurgery, Inc. →

Questions

AI-generated answers, 1 Oct 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 the Macropore Cardio-Wrap (TS) used for?

    The Macropore Cardio-Wrap (TS) is a resorbable pericardial patch designed specifically for pericardium replacement in patients who may require re-operation within six months. Its flexible, malleable construction allows surgeons to tailor it to the patient’s anatomy during revision surgeries, reducing the need for additional materials or complex repairs.

  • How is the Macropore Cardio-Wrap (TS) supplied and prepared for use?

    The Macropore Cardio-Wrap (TS) is supplied sterile and intended for single-use only. It comes as a sheet-form implant made from poly lactic acid (PLA), which can be cut to size using scissors or shaped with the Macropore Power Pen for precise customization during surgery. Always follow sterile handling protocols to maintain integrity.

  • Is the Macropore Cardio-Wrap (TS) reusable or MRI-safe?

    The Macropore Cardio-Wrap (TS) is designed for single-use only and must not be reused. Additionally, it is not MRI-safe, so patients must be monitored accordingly if MRI imaging is required post-implantation. Always verify compatibility with imaging modalities before use.

  • What storage and handling precautions should be taken with this device?

    The Macropore Cardio-Wrap (TS) must be stored according to the manufacturer’s instructions provided in the accompanying documentation. Since it is sterile, it should remain in its sealed packaging until immediately before use. Avoid exposure to moisture, heat, or contamination, and handle with sterile techniques to prevent compromise of sterility.

  • Can this patch be used in patients who may need follow-up surgery within six months?

    Yes, the Macropore Cardio-Wrap (TS) is explicitly designed for patients who may require re-operation within six months. Its resorbable PLA material is intended to provide temporary structural support while the body’s natural healing processes take place, minimizing complications if revision surgery becomes necessary.