Hemashield Woven Double Velour Grafts 7mmx100cm
FDA PMAClass II (US FDA PMA)
Identity
- Trade Name
- MICROVEL(R) WITH HEMASHIELD FDA PMA
- Generic Name
- PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER FDA PMA
Identifiers
- PMA Number
- P840029 FDA PMA
- FDA Product Code
- DSY FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 870.3450 FDA PMA
- Regulation Number
- 870.3450 FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APRL FDA PMA
This device is a vascular graft prosthesis with a diameter of 6mm or greater, classified under the generic name Prosthesis, Vascular Graft, Of 6mm And Greater Diameter. It is designed as a synthetic conduit to replace or bypass damaged or diseased blood vessels, providing durable vascular support in cardiovascular procedures.
The Hemashield Woven Double Velour Grafts are supplied sterile and intended for single-use in surgical settings. They are regulated under FDA Premarket Approval (PMA) with the approval number P840029 and fall under device classification DSY. The grafts are manufactured in a 7mm diameter by 100cm length and must be stored according to manufacturer instructions to maintain sterility and integrity.
Frequently asked questions
What is the primary use of the Hemashield Woven Double Velour Grafts in surgical procedures?
The Hemashield Woven Double Velour Grafts are designed as synthetic vascular conduits to replace or bypass damaged or diseased blood vessels in cardiovascular procedures. They provide durable vascular support where natural vessels are compromised, ensuring continued blood flow.
Are these grafts intended for reuse, or are they meant to be used only once?
These grafts are explicitly intended for single-use in surgical settings. They are supplied sterile and should not be reused to maintain safety and sterility standards.
What size and length are available for the Hemashield Woven Double Velour Grafts, and how does this fit common clinical needs?
The Hemashield Woven Double Velour Grafts come in a single size: a 7mm diameter by 100cm length, which is suitable for medium-caliber vascular bypass or replacement procedures. This dimension is commonly used in coronary artery bypass grafting (CABG) or peripheral vascular surgeries.
How should these grafts be stored to ensure they remain sterile and intact?
The grafts must be stored according to the manufacturer’s instructions to preserve sterility and structural integrity. Since they are sterile upon packaging, they should be kept in a clean, dry environment away from direct sunlight or extreme temperatures until use.
What regulatory pathway does this device follow, and what does that mean for clinicians?
The Hemashield Woven Double Velour Grafts follow the FDA Premarket Approval (PMA) pathway, indicated by approval number P840029. This means the device has undergone rigorous clinical evaluation to ensure safety and effectiveness before market authorization, providing clinicians with confidence in its regulatory standing.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P840029 | Class II | Active |
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Manufacturer
- Manufacturer
- Maquet Cardiovascular LLC
- FDA Applicant
- Maquet Cardiovascular, LLC
Sources (1)
- FDA PMA P840029 24 fields · synced Sep 18, 2026