Identity
- Trade Name
- SURGIKOS ARTIGRAFT FDA PMA
- Generic Name
- Tissue graft of 6mm and greater FDA PMA
Identifiers
- PMA Number
- N16837 FDA PMA
- FDA Product Code
- LXA FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
- PMA Supplement
- S001 FDA PMA
The Artegraft Collagen Vascular Graft is a tissue graft classified as a Tissue Graft of 6mm and Greater, designed for vascular reconstruction. It is constructed from collagen-based material intended to provide structural support and patency in surgical bypass procedures, particularly in the cardiovascular system.
This graft is supplied sterile and intended for single-use in controlled surgical environments. It is regulated under an FDA Premarket Approval (PMA) with PMA number N16837 and falls under Device Class III. Available in sizes of 6mm and greater, it is intended for use in vascular surgeries where synthetic or autologous grafts may be required, adhering to strict sterility and handling protocols.
Frequently asked questions
What types of surgical procedures is the Artegraft Collagen Vascular Graft primarily used for?
The Artegraft Collagen Vascular Graft is specifically designed for vascular reconstruction in surgical bypass procedures within the cardiovascular system. It provides structural support and helps maintain patency (open flow) in situations where synthetic or autologous (patient-derived) grafts are needed, such as in complex arterial bypasses or reconstructions.
Is the Artegraft Collagen Vascular Graft intended for reuse, or is it meant to be used only once?
The Artegraft Collagen Vascular Graft is explicitly labeled for **single-use only** in controlled surgical environments. This ensures sterility and safety, as reuse could compromise its integrity and risk infection or graft failure.
What sizes are available for the Artegraft Collagen Vascular Graft, and how might this affect my selection?
The Artegraft Collagen Vascular Graft is available in sizes **6mm and greater**, allowing flexibility for various vascular diameters in bypass procedures. The size selection should align with the patient’s anatomy and the specific surgical requirements to ensure proper fit and function during reconstruction.
How is the Artegraft Collagen Vascular Graft regulated, and what does that mean for its use?
The Artegraft Collagen Vascular Graft is regulated under an **FDA Premarket Approval (PMA)** with PMA number **N16837**, classifying it as a **Class III device**. This means it has undergone rigorous review by the FDA to ensure safety and effectiveness for its intended use in vascular reconstruction, adhering to strict manufacturing and performance standards.
What storage or handling precautions should be taken with the Artegraft Collagen Vascular Graft before use?
Since the Artegraft Collagen Vascular Graft is supplied **sterile**, it must be stored according to the manufacturer’s instructions to maintain sterility until use. This typically includes keeping it in a sealed, dry environment away from direct sunlight or extreme temperatures. Always follow the provided packaging guidelines to prevent contamination or degradation before surgery.
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 | N16837 | Class III | Active |
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Manufacturer
- Manufacturer
- LeMaitre Vascular, Inc.
Sources (1)
- FDA PMA N16837 23 fields · synced Sep 18, 2026