Cardioroot Woven Collagen Coated Vascular Prostheses
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K103347 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 Cardioroot Woven Collagen Coated Vascular Prostheses are polyester vascular grafts designed for use in complex aortic root surgeries. These devices feature an external velour surface and a non-velour inner surface, with a water permeability of less than 5ml/cm2/min.
This device is classified as a vascular graft of 6mm and greater diameter and is magnetic resonance safe. It has received FDA 510(k) clearance and is manufactured by Intervascular SAS.
Frequently asked questions
What is the intended use of the Cardioroot vascular prosthesis?
The Cardioroot Woven Collagen Coated Vascular Prostheses are designed specifically for use in complex aortic root surgical procedures.
What are the physical characteristics of this graft?
These polyester grafts feature an external velour surface and a non-velour inner surface. They are engineered with a water permeability of less than 5ml/cm2/min and are available in diameters of 6mm and greater.
Is this device safe for use with magnetic resonance imaging?
Yes, the Cardioroot Woven Collagen Coated Vascular Prostheses are classified as magnetic resonance safe, allowing for imaging procedures to be performed on patients with this implant.
What is the regulatory status of this device?
The Cardioroot Woven Collagen Coated Vascular Prostheses have received FDA 510(k) clearance under the cardiovascular medical specialty, confirming they have been found substantially equivalent to legally marketed predicate devices.
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: Cardioroot Woven Aortic Graft - Getinge, PDF Cardioroot Aortic Graft - getinge.com, K103347 FDA 510(k) - CARDIOROOT WOVEN COLLAGEN COATED VASCUL...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K103347 | Class II | Active |
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Manufacturer
- Manufacturer
- Intervascular Sas
Sources (1)
- FDA 510(k) K103347 24 fields · synced Sep 22, 2026