16 results
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16ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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Ovation Prime Abdominal Stent Graft System; Manufacturer: TriVascular, Inc. 3910 Brickway Blvd. Santa Rosa, CA 95403 The TriVascular Ovation Prime Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required.
FDA Enforcement
Class II
·Terminated·Trivascular, Inc·April 2, 2014
The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft impregnated with highly purified bovine collagen. The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is designed to reduce bleeding at implant and thereby eliminates the operative preclotting step, including cumbersome autoclave techniques. The collagen is designed to be gradually resorbed by the patient. The CONCENTRICRIMP pleat and GUIDELINE stripe are also featured. In addition to collagen, the graft also contains glycerol as a softening agent.
FDA Enforcement
Class II
·Terminated·GETINGE US SALES LLC·October 2, 2019
Bard Distaflo Vascular Bypass Graft; Product Code: DF8006SC; 6 mm x 80 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels.
FDA Enforcement
Class II
·Terminated·Bard Peripheral Vascular Inc·February 17, 2016
Bard Distaflo Vascular Bypass Graft; Product Code: DF6006SC; 8 mm x 60 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels.
FDA Enforcement
Class II
·Terminated·Bard Peripheral Vascular Inc·February 17, 2016
INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour surface and non-velour inner surface. The device is available in straight tubes and bifurcated configurations, as well as hemabridge, aortic arch, thoracic aortic graft, and cardioroot configurations designed for use on the thoracic aorta
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 29, 2022
The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg Extension Stent-Graft, a Proximal Cuff Stent-Graft and a Straight Iliac Extension Stent-Graft. Each stent-graft is preloaded into its own delivery system that is advanced under fluoroscopy to the location of the infrarenal aneurysm. The stent-graft is deployed at the intended location and creates a blood flow channel, excluding the aneurysm from blood pressure and flow.
FDA Enforcement
Class II
·Ongoing·Bolton Medical Inc.·June 14, 2023
FLAIR Endovascular Stent Graft, Product Code: FAS08070, FAF08070, Implant Size: 8mmx70mm The FLAIR Endovascular Stent Graft (implant) is a flexible, self-expanding endoprosthesis comprised of expanded polytetrafluoroethylene (ePTFE) encapsulating a Nitinol stent framework. The FLAIR Endovascular Stent Graft is available in both flared and straight configurations. The distal end of the flared configuration devices are approximately 4mm larger in diameter than the body section.
FDA Enforcement
Class II
·Terminated·Bard Peripheral Vascular Inc·November 11, 2015
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175912P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·May 13, 2020
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175820P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·May 13, 2020
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175914P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·May 13, 2020
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175822P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·May 13, 2020
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175832P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·May 13, 2020
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175824P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·May 13, 2020
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175826P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·May 13, 2020
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175828P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·May 13, 2020
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175830P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·May 13, 2020