RX Accunet Embolic Protection System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K153086 FDA 510(k)
- FDA Product Code
- NTE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The RX Accunet Embolic Protection System is a filtration-type embolic protection device designed to contain and remove embolic material, such as thrombus or debris, during carotid stenting and angioplasty interventions. It features a nickel-titanium filter basket that is deployed distal to the interventional site to provide capture capabilities.
The system consists of a delivery system and two recovery catheters to accommodate varying patient anatomies. This device is regulated under FDA 510(k) clearance and is classified as a temporary carotid catheter for embolic capture.
Frequently asked questions
What is the primary function of the RX Accunet Embolic Protection System?
This device is designed to contain and remove embolic material, such as thrombus or debris, that may be released during carotid stenting and angioplasty interventions. It utilizes a nickel-titanium filter basket deployed distal to the interventional site to capture this material.
How is the system configured to accommodate different patients?
The system is supplied with a delivery system and two distinct recovery catheters. This configuration allows clinicians to select the appropriate components to accommodate varying patient anatomies during the procedure.
What is the regulatory status of this device?
The RX Accunet Embolic Protection System is regulated under FDA 510(k) clearance. It is classified as a temporary carotid catheter for embolic capture, falling under regulation number 870.1250.
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 Abbott Vascular RX Accunet® Embolic Protection System - U.S., DeviceMD - RX ACCUNET EMBOLIC PROTECTION SYSTEM, Abbott Accunet RX Embolic Protection System - Medical XPRT
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K153086 | Class II | Active |
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Manufacturer
- Manufacturer
- Abbott Vascular
Sources (1)
- FDA 510(k) K153086 24 fields · synced Sep 22, 2026