Identifiers
- 510(k) Number
- K130142 FDA 510(k)
- FDA Product Code
- DSY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3450 FDA 510(k)
- Regulation Number
- 870.3450 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Flixene IFG Vascular Graft is a composite vascular prosthesis designed for arterial vascular reconstruction and segmental bypass procedures. Constructed using a proprietary biomaterial lamination process, it incorporates a reinforced nitinol support section for intraluminal stability, with multiple expanded polytetrafluoroethylene (ePTFE) layers to enhance strength and handling.
This device is supplied sterile and intended for single-use in cardiovascular applications. Available in diameters of 6mm and greater, it is regulated under FDA 510(k) clearance (K130142) and classified as a Class II medical device (DSY). Storage and handling must comply with sterile surgical protocols, and its design adheres to regulatory standards for vascular grafts outlined in 21 CFR 870.3450.
Frequently asked questions
What types of surgical procedures is the Flixene IFG Vascular Graft designed for?
The Flixene IFG Vascular Graft is specifically designed for arterial vascular reconstruction and segmental bypass procedures. Its reinforced nitinol support section and multiple ePTFE layers make it suitable for applications requiring stability and durability in cardiovascular surgeries.
Is the Flixene IFG Vascular Graft intended for reuse, or is it meant to be used only once?
The Flixene IFG Vascular Graft is supplied sterile and explicitly intended for single-use only. This aligns with standard sterile surgical protocols to ensure patient safety and device integrity.
What diameters are available for the Flixene IFG Vascular Graft, and how does this affect its use?
The Flixene IFG Vascular Graft is available in diameters of 6mm and greater, making it suitable for a range of arterial bypass and reconstruction procedures where larger vessel support is required. The reinforced nitinol core and ePTFE layers provide structural stability across these sizes.
How should the Flixene IFG Vascular Graft be stored, and what precautions should be taken?
Since the Flixene IFG Vascular Graft is sterile, it must be stored and handled according to sterile surgical protocols to maintain its integrity. This includes keeping it in its original packaging until use and ensuring the environment remains clean and uncontaminated, as per regulatory standards for vascular grafts.
What regulatory pathway was followed for the Flixene IFG Vascular Graft, and what does this mean for its use?
The Flixene IFG Vascular Graft received FDA 510(k) clearance (K130142) under the Traditional pathway, with a decision of *Substantially Equivalent* by the Cardiovascular (CV) Advisory Committee. This means it was determined to be as safe and effective as a legally marketed predicate device, adhering to Class II medical device standards (product code DSY) for vascular grafts.
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: Flixene - IFG - Implantation - Brochure 0341C PDF, FLIXENE IFG VASCULAR GRAFT (K130142) — FDA 510(k) | Innolitics, Flixene Vascular Graft - Getinge, Flixene Vascular Graft - Getinge
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K130142 | Class II | Active |
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Manufacturer
- Manufacturer
- Atrium Medical Corporation
Sources (1)
- FDA 510(k) K130142 24 fields · synced Sep 18, 2026