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Sign in to claim this brandVeniti Inc
US
Last updated May 25, 2026
What Veniti Inc makes
Veniti Inc manufactures bare-metal peripheral venous stents designed for treating venous obstructions in the legs and other peripheral veins. Their portfolio includes self-expanding stent systems intended for endovascular placement to restore blood flow in chronic venous insufficiency or post-thrombotic syndrome cases. The devices are delivered via catheter-based techniques and are engineered for use in deep and superficial venous systems.
The company’s venous stents fall under FDA Class III regulation, requiring premarket approval (PMA) or a humanitarian device exemption (HDE) for market authorisation. These devices are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance tracking under US regulatory requirements. Veniti Inc operates from the United States, adhering to FDA standards for medical device development and commercialisation.
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 Veniti Inc manufacture?
Veniti Inc specializes in bare-metal peripheral venous stents. These devices are designed to treat venous obstructions in peripheral veins, such as those in the legs, by restoring blood flow. They are intended for use in conditions like chronic venous insufficiency or post-thrombotic syndrome and are deployed via catheter-based techniques in deep and superficial venous systems.
Where is Veniti Inc based, and how does that affect its regulatory compliance?
Veniti Inc is based in the United States, which means its devices must comply with FDA regulations. Since its venous stents fall under Class III classification, they require either Premarket Approval (PMA) or a Humanitarian Device Exemption (HDE) for market authorization. This classification reflects the higher risk associated with these devices, necessitating rigorous pre-market evaluation.
Are Veniti Inc’s devices listed in any regulatory registries, and why does this matter?
Yes, Veniti Inc’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability, transparency, and compliance tracking for each device, which is critical for regulatory oversight, post-market surveillance, and patient safety. Listing in the UDI database helps healthcare providers and regulators verify device authenticity and recall status.
How are Veniti Inc’s venous stents classified by regulatory authorities, and what does that mean for their use?
Veniti Inc’s venous stents are classified as FDA Class III devices, the highest risk category under US regulations. This classification means they are considered to support or sustain human life, be implanted, or present a potential unreasonable risk of illness or injury if they fail. As a result, these devices require premarket approval (PMA) or a humanitarian device exemption (HDE) before they can be legally marketed in the US.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 079757164
Catalogue (18)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Vici Venous Stent ® System | H74916090100 | FDA UDI | Class III | Active |
| VICI RDS™ Venous Stent System | H74914060710 | FDA UDI | Class III | Active |
| Vici Venous Stent ® System | H74914090100 | FDA UDI | Class III | Active |
| VICI RDS™ Venous Stent System | H74912060710 | FDA UDI | Class III | Active |
| VICI RDS™ Venous Stent System | H74912120790 | FDA UDI | Class III | Active |
| Vici Venous Stent ® System | H74912120100 | FDA UDI | Class III | Active |
| Vici Venous Stent ® System | H74912060100 | FDA UDI | Class III | Active |
| VICI RDS™ Venous Stent System | H74916090750 | FDA UDI | Class III | Active |
| VICI RDS™ Venous Stent System | H74916060710 | FDA UDI | Class III | Active |
| VICI RDS™ Venous Stent System | H74914090750 | FDA UDI | Class III | Active |
| VICI RDS™ Venous Stent System | H74912090750 | FDA UDI | Class III | Active |
| Vici Venous Stent ® System | H74916120100 | FDA UDI | Class III | Active |
| Vici Venous Stent ® System | H74914060100 | FDA UDI | Class III | Active |
| Vici Venous Stent ® System | H74916060100 | FDA UDI | Class III | Active |
| VICI RDS™ Venous Stent System | H74914120790 | FDA UDI | Class III | Active |
| VICI RDS™ Venous Stent System | H74916120790 | FDA UDI | Class III | Active |
| Vici Venous Stent ® System | H74914120100 | FDA UDI | Class III | Active |
| Vici Venous Stent ® System | H74912090100 | FDA UDI | Class III | Active |
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