Identifiers
- 510(k) Number
- K260091 FDA 510(k)
- FDA Product Code
- DYB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1340 FDA 510(k)
- Regulation Number
- 870.1340 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Aventus Introducer Sheath is a percutaneous vascular access device designed as a conduit for endovascular procedures. It facilitates the insertion of catheters and other endovascular devices while reducing blood loss during vascular access. Constructed as a catheter-based sheath, it is intended for use in minimally invasive cardiovascular interventions. Its primary function is to provide stable access and hemostasis during catheter-based therapies.
The device is supplied in three French sizes and varying working lengths, intended for single-use applications. It is intended for use in standard venous access procedures and is regulated under FDA 510(k) clearance (K260091) as a substantially equivalent cardiovascular device. Sterility and packaging details are not specified in the provided data, but it is classified under product code DYB for introducer sheaths. No additional regulatory markings or MRI safety classifications are noted.
Frequently asked questions
What is the Aventus Introducer Sheath used for?
The Aventus Introducer Sheath is designed as a percutaneous vascular access device to serve as a conduit for endovascular procedures. It facilitates the insertion of catheters and other devices while minimizing blood loss during vascular access. This makes it ideal for stable access and hemostasis in minimally invasive cardiovascular interventions, such as catheter-based therapies.
How is the Aventus Introducer Sheath supplied?
The device is supplied in three French sizes with varying working lengths, tailored for single-use applications. This ensures compatibility with a range of venous access procedures while maintaining sterility and usability for one-time clinical use.
Is the Aventus Introducer Sheath intended for reuse?
No, the Aventus Introducer Sheath is explicitly designed for single-use only. This design choice aligns with best practices for minimizing infection risk and ensuring patient safety during vascular procedures.
What regulatory pathway does the Aventus Introducer Sheath follow?
The Aventus Introducer Sheath has received FDA 510(k) clearance under the classification of substantially equivalent (SESE) devices, with a clearance number of K260091. It falls under product code DYB for introducer sheaths and was reviewed by the Cardiovascular (CV) Advisory Committee.
Are there specific sizes available for the Aventus Introducer Sheath?
Yes, the device is available in three French sizes, each paired with varying working lengths to accommodate different procedural needs. This modularity allows clinicians to select the appropriate sheath based on patient anatomy and the specific requirements of the endovascular intervention.
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: Introducer Sheath - Inquis Medical, Electronic-IFU - Inquis Medical, Aventus Introducer Sheath (K260091) — FDA 510(k) | Innolitics, K260091 FDA 510(k) - Aventus Introducer Sheath | Inquis Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K260091 | Class II | Active |
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Manufacturer
- Manufacturer
- Inquis Medical
Sources (1)
- FDA 510(k) K260091 24 fields · synced Oct 1, 2026