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Trivascular, Inc.

Last updated May 25, 2026

What Trivascular, Inc. makes

Trivascular, Inc. manufactures endovascular stent-graft systems designed for the treatment of abdominal aortic aneurysms. Their portfolio includes devices specifically intended for placement in the aortoiliac region, such as the Ovation Prime and Ovation iX systems, which are tailored for endovascular aneurysm repair.

These devices fall under Class III regulatory classification in the US, requiring premarket approval (PMA) or a humanitarian device exemption (HDE). They are listed in the FDA’s Unique Device Identifier (UDI) database, reflecting their authorised status for commercial distribution in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Trivascular, Inc. manufacture?

Trivascular, Inc. specializes in endovascular stent-graft systems, specifically designed for the treatment of abdominal aortic aneurysms. Their primary focus is on aortoiliac endovascular stent-grafts, such as the Ovation Prime and Ovation iX systems, which are used in endovascular aneurysm repair procedures.

Where is Trivascular, Inc. based?

Trivascular, Inc. is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework, as it operates under the FDA’s jurisdiction for device authorisation.

Which regulatory registries list Trivascular, Inc.’s devices?

Trivascular, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for authorised devices in the United States, confirming their compliance with FDA requirements for commercial distribution.

How are Trivascular, Inc.’s devices classified under US regulations?

Trivascular’s devices fall under Class III regulatory classification in the US. This classification applies to high-risk medical devices that require rigorous premarket approval (PMA) or a humanitarian device exemption (HDE) to ensure safety and effectiveness before commercialisation.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
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PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 826179819

Catalogue (42)

Device	Model / Reference	Registries	Class	Status
Ovation Prime Adominal Stent Graft System	Aortic Body	FDA UDI	Class III	Active
Ovation Prime Abdominal Stent Graft System	Iliac Limb	FDA UDI	Class III	Active
Ovation Prime Abdominal Stent Graft System	Iliac Limb	FDA UDI	Class III	Active
Ovation Prime Abdominal Stent Graft System	Iliac Extension	FDA UDI	Class III	Active
Ovation Prime Abdominal Stent Graft System	Iliac Extension	FDA UDI	Class III	Active
Ovation Prime Abdominal Stent Graft System	Iliac Extension	FDA UDI	Class III	Active
Ovation Prime Abdominal Stent Graft System	Autoinjector	FDA UDI	Class III	Active
Ovation Prime Abdominal Stent Graft System	Iliac Limb	FDA UDI	Class III	Active
Ovation Prime Abdominal Stent Graft System	Iliac Extension	FDA UDI	Class III	Active
Ovation Prime Abdominal Stent Graft System	Iliac Limb	FDA UDI	Class III	Active
Ovation iX Abdominal Stent Graft System	Aortic Body	FDA UDI	Class III	Active
Ovation Prime Abdominal Stent Graft System	Iliac Limb	FDA UDI	Class III	Active
Ovation Prime Abdominal Stent Graft System	Aortic Body	FDA UDI	Class III	Active
Ovation Prime Abdominal Stent Graft System	Iliac Limb	FDA UDI	Class III	Active
Ovation Prime Abdominal Stent Graft System	Iliac Limb	FDA UDI	Class III	Active
Ovation Prime Abdominal Stent Graft System	Iliac Extension	FDA UDI	Class III	Active
Ovation Prime Abdominal Stent Graft System	Iliac Limb	FDA UDI	Class III	Active
Ovation Prime Abdominal Stent Graft System	Iliac Limb	FDA UDI	Class III	Active
Ovation Prime Abominal Stent Graft System	Iliac Limb	FDA UDI	Class III	Active
Ovation Prime Abdominal Stent Graft System	Iliac Limb	FDA UDI	Class III	Active
Ovation Prime Abdominal Stent Graft System	Iliac Limb	FDA UDI	Class III	Active
Ovation iX Abdominal Stent Graft System	Aortic Body	FDA UDI	Class III	Active
Ovation iX Abdominal Stent Graft System	Aortic Body	FDA UDI	Class III	Active
Ovation Prime Abdominal Stent Graft System	Aortic Body	FDA UDI	Class III	Active
Ovation Prime Abdominal Stent Graft System	Aortic Body	FDA UDI	Class III	Active
Ovation Prime Abdominal Stent Graft System	Iliac Limb	FDA UDI	Class III	Active
Ovation Prime Abdominal Stent Graft System	Iliac Limb	FDA UDI	Class III	Active
Ovation Prime Abdominal Stent Graft System	Fill Polymer Kit	FDA UDI	Class III	Active
Ovation Prime Abdominal Stent Graft System	Iliac Limb	FDA UDI	Class III	Active
Ovation Prime Abdominal Stent Graft System	Iliac Limb	FDA UDI	Class III	Active
Ovation Prime Abdominal Stent Graft System	Iliac Limb	FDA UDI	Class III	Active
Ovation Prime Abdominal Stent Graft System	Iliac Limb	FDA UDI	Class III	Active
Ovation Prime Abdominal Stent Graft System	Iliac Extension	FDA UDI	Class III	Active
Ovation Prime Abdominal Stent Graft System	Iliac Limb	FDA UDI	Class III	Active
Ovation Prime Abdominal Stent Graft System	Iliac Limb	FDA UDI	Class III	Active
Ovation Prime Abdominal Stent Graft System	Iliac Limb	FDA UDI	Class III	Active
Ovation iX Abdominal Stent Graft System	Aortic Body	FDA UDI	Class III	Active
Ovation Prime Abdominal Stent Graft System	Aortic Body	FDA UDI	Class III	Active
Ovation Prime Abdominal Stent Graft System	Iliac Limb	FDA UDI	Class III	Active
Ovation Prime Abdominal Stent Graft System	Iliac Limb	FDA UDI	Class III	Active
Ovation Prime Abdominal Stent Graft System	Iliac Limb	FDA UDI	Class III	Active
Ovation iX Abdominal Stent Graft System	Aortic Body	FDA UDI	Class III	Active

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