Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K193379 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 and Fogarty Biliary Balloon Probe are interventional devices designed for the removal of emboli and thrombi from arterial and biliary circulatory systems. These catheters employ an inflatable balloon mechanism to engage and dislodge obstructions, facilitating restoration of blood or bile flow through targeted vessels. The arterial catheter is specifically engineered for use in peripheral arteries, while the biliary probe is tailored for biliary tract applications. Both devices are classified under Class II medical devices, indicating their regulated use in clinical settings requiring performance standards and safety oversight.
These catheters are supplied as single-use, sterile devices, intended for use in surgical or interventional environments. The arterial catheter features a PVC or nylon body with lengths ranging from 40 to 80 cm, and the biliary probe is designed for precise navigation within the biliary system. The devices are approved under the FDA’s 510(k) pathway, demonstrating substantial equivalence to prior generations. No MRI safety information is specified, and proper storage adheres to standard sterile medical device protocols to maintain integrity until use.
Frequently asked questions
What are the Fogarty Arterial Embolectomy Catheter and Fogarty Biliary Balloon Probe used for?
These devices are designed to remove emboli (blood clots) and thrombi from blocked arteries or bile ducts. The Fogarty Arterial Embolectomy Catheter targets peripheral arteries, while the Fogarty Biliary Balloon Probe is specifically engineered for the biliary tract. Both use an inflatable balloon to engage and dislodge obstructions, restoring blood or bile flow.
Are these catheters single-use or reusable?
The Fogarty Arterial Embolectomy Catheter and Fogarty Biliary Balloon Probe are single-use devices. They are supplied sterile and intended for one-time clinical use only, ensuring patient safety and compliance with sterile procedure protocols.
What materials are used in the Fogarty Arterial Embolectomy Catheter?
The arterial catheter features a PVC or nylon body, with lengths ranging from 40 cm to 80 cm. These materials are chosen for durability, flexibility, and compatibility with interventional procedures while maintaining structural integrity during use.
How should these devices be stored before use?
Both catheters must be stored according to standard sterile medical device protocols to preserve their integrity. They are packaged sterile and should remain unopened until immediately before use. Proper storage conditions—such as dry, clean environments away from direct sunlight—are critical to maintaining sterility and functionality.
What regulatory pathway was followed for these devices?
The Fogarty Arterial Embolectomy Catheter and Fogarty Biliary Balloon Probe were cleared under the FDA’s 510(k) pathway, demonstrating substantial equivalence to prior generations of these devices. This classification falls under Class II medical devices, requiring compliance with performance standards and safety oversight.
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 Fogarty Arterial Embolectomy Catheter - eifu.edwards.com, Clot management - Edwards Lifesciences, Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K193379 | Class II | Active |
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Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
- FDA Applicant
- Edwards Lifesciences, LLC
Sources (1)
- FDA 510(k) K193379 24 fields · synced Oct 1, 2026