Identifiers
- 510(k) Number
- K220270 FDA 510(k)
- FDA Product Code
- QEW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5150 FDA 510(k)
- Regulation Number
- 870.5150 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Aspirex Thrombectomy System is a Peripheral Mechanical Thrombectomy With Aspiration device, designed to mechanically remove thrombi from peripheral blood vessels. It employs aspiration and mechanical fragmentation to clear occlusions in hemodialysis access grafts and native arteriovenous fistulas, restoring vascular patency.
The system is supplied as a sterile, single-use device intended for use in peripheral vascular procedures. It is classified as Class II under FDA regulations (21 CFR 870.5150) and has received FDA 510K clearance under the Traditional 510(k) pathway. Compliance with sterility and procedural guidelines ensures safe use in vascular interventional settings.
Frequently asked questions
What types of blood vessels is the Aspirex Thrombectomy System designed to treat, and how does it work?
The Aspirex Thrombectomy System is specifically designed to remove thrombi (blood clots) from peripheral blood vessels, including hemodialysis access grafts and native arteriovenous (AV) fistulas. It combines mechanical fragmentation and aspiration to break up and suction out clots, restoring blood flow and maintaining vascular patency in these critical access sites.
Is the Aspirex Thrombectomy System intended for single-use or repeated use, and how should it be stored?
The Aspirex Thrombectomy System is a sterile, single-use device. It should be stored in its original packaging, protected from contamination and physical damage, and kept in a clean, dry environment as per manufacturer guidelines to ensure sterility and functionality.
What regulatory pathway was used for FDA clearance of the Aspirex Thrombectomy System, and what class does it fall under?
The Aspirex Thrombectomy System received FDA clearance through the Traditional 510(k) pathway under the *Substantially Equivalent* determination. It is classified as a Class II medical device (21 CFR 870.5150), which is the standard regulatory classification for mechanical thrombectomy devices.
How is the Aspirex Thrombectomy System supplied, and is it compatible with standard interventional procedures?
The system is supplied as a complete, sterile, single-use kit, ready for immediate use in peripheral vascular interventional procedures. Its design aligns with standard thrombectomy workflows, making it suitable for use in vascular interventional settings where hemodialysis access or AV fistula patency is critical.
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: PDF C.R. Bard, Inc. Aaron Conovaloff Regulatory Affairs Manager Trade ..., PDF C.R. Bard, Inc. Aaron Conovaloff Regulatory Affairs Manager, Aspirex™ Mechanical Aspiration Thrombectomy System - BD
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220270 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K220270 24 fields · synced Sep 19, 2026