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Cardio-Wrap

FDA 510(k)

Class II (US FDA 510(k))

510(k) K090637

by Mast Biosurgery Usa Inc.

Identifiers

510(k) Number
K090637 FDA 510(k)
FDA Product Code
DXZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.3470 FDA 510(k)
Regulation Number
870.3470 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESU FDA 510(k)

The Cardio-Wrap Bioresorbable Sheet is a Patch, Pledget, and Intracardiac Device composed of a 70:30 Poly(L-lactide-co-D,L-lactide) copolymer. It functions as a bioresorbable barrier designed to support pericardial defect coverage and facilitate postsurgical healing in cardiothoracic procedures. The material is engineered to degrade over time, reducing the need for long-term foreign-body presence.

This device is supplied sterile and intended for single-use in cardiac surgery settings. It is classified as a Class II medical device under FDA regulations (K090637, 510(k) clearance) and is available in a standard size of 100 x 130 x 0.05mm. Storage requires protection from moisture and extreme temperatures. Its primary indication, as referenced in submissions, is pericardial defect coverage, though clinical use is governed by surgical discretion.

Frequently asked questions

What is the Cardio-Wrap bioresorbable sheet designed for?

The Cardio-Wrap is engineered as a bioresorbable barrier to cover pericardial defects during cardiothoracic procedures. Its primary purpose is to provide structural support while the surgical site heals, then gradually degrade over time. This reduces the need for permanent foreign-body implantation, which can help lower long-term risks associated with retained materials.

How is the Cardio-Wrap supplied and what are its storage requirements?

The Cardio-Wrap is supplied sterile and intended for single-use only in cardiac surgery settings. To maintain integrity, it must be stored protected from moisture and extreme temperatures. Proper storage ensures the material remains effective and uncontaminated until use.

What size is available for the Cardio-Wrap, and can it be customized?

The Cardio-Wrap is currently available in a standard size of 100 x 130 x 0.05mm. The device is not designed for customization, and surgical discretion should guide its application based on the patient’s specific anatomical needs.

Is the Cardio-Wrap reusable, or is it intended for single-use?

The Cardio-Wrap is explicitly intended for single-use only. Its bioresorbable material is engineered to degrade post-implantation, making reuse unsafe and ineffective. Single-use ensures sterility and compliance with surgical best practices.

What material is the Cardio-Wrap made from, and how does it degrade?

The Cardio-Wrap is composed of a 70:30 copolymer blend of Poly(L-lactide-co-D,L-lactide). This material is designed to undergo controlled bioresorption over time, gradually breaking down into non-toxic byproducts that the body can absorb. This process reduces the need for long-term foreign-body retention.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CardioWrap® Bioresorbable Sheet | MAST Biosurgery, CardioWrap® Bioresorbable Adhesion Film | MAST Biosurgery, MAST BIOSURGERY USA INC. 36204-01 CardioWrap® - RevMed, CardioWrap® 100 x 130 x 0.05mm Bioresorbable protective sheet made from ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Mast Biosurgery Usa Inc.
FDA Applicant
Mast Biosurgery USA, Inc.

Sources (1)

  • FDA 510(k) K090637 24 fields · synced Oct 1, 2026