Fogarty Arterial Embolectomy Catheter with Gate Valve
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K233820 FDA 510(k)
- FDA Product Code
- DXE 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 Fogarty Arterial Embolectomy Catheter with Gate Valve is a catheter device used for embolectomy procedures. It is designed to remove blood clots from arteries, restoring blood flow in vascular systems.
This device is supplied as a single-use catheter and is regulated under FDA 510K clearance with product code DXE. It is manufactured by Edwards Lifesciences and is intended for use in cardiovascular procedures. The device is available in various sizes as specified by the manufacturer.
Frequently asked questions
What is the Fogarty Arterial Embolectomy Catheter with Gate Valve used for?
This catheter is specifically designed for embolectomy procedures to remove blood clots from arteries, thereby restoring blood flow in vascular systems during cardiovascular procedures.
Is the Fogarty Arterial Embolectomy Catheter with Gate Valve single-use or reusable?
The device is supplied as a single-use catheter, meaning it should be used for one procedure only and then discarded to ensure patient safety and device performance.
What sizes are available for the Fogarty Arterial Embolectomy Catheter with Gate Valve?
The device is available in various sizes as specified by the manufacturer, allowing clinicians to select the appropriate size for different arterial anatomies and clinical requirements.
What is the regulatory status of the Fogarty Arterial Embolectomy Catheter with Gate Valve?
This device is regulated under FDA 510K clearance with product code DXE, indicating it has been determined to be substantially equivalent to predicate devices already on the market for embolectomy procedures.
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: Clot-Management - Edwards Lifesciences, Fogarty™ Occlusion Catheters - BD
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233820 | Class II | Active |
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Manufacturer
- Manufacturer
- Edwards Lifesciences
Sources (1)
- FDA 510(k) K233820 24 fields · synced Sep 23, 2026