Pruitt F3 Outlying and Inlying Carotid Shunt (With and Without T-Port)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K051067 FDA 510(k)
- FDA Product Code
- MJN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4450 FDA 510(k)
- Regulation Number
- 870.4450 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pruitt F3 Outlying and Inlying Carotid Shunt is a temporary intravascular occluding catheter designed to maintain blood flow between the common carotid and internal carotid arteries during carotid endarterectomy procedures. It features occlusion balloons at both ends to secure placement within the vessel, ensuring patency while minimizing trauma and enabling visualization of plaque endpoints.
This device is supplied sterile and intended for single-use in controlled surgical environments. It is classified as a Class II medical device under FDA regulations (21 CFR 870.4450) and holds a Special 510(k) clearance (K051067) from the FDA’s Cardiovascular Advisory Committee. Available in multiple sizes and configurations, including versions with and without a T-port, the shunt requires no external clamps and is compatible with standard surgical settings. Storage and handling must adhere to sterile medical device protocols.
Frequently asked questions
What is the Pruitt F3 Outlying and Inlying Carotid Shunt used for?
The Pruitt F3 Outlying and Inlying Carotid Shunt is designed to maintain blood flow between the common carotid and internal carotid arteries during carotid endarterectomy procedures. It ensures patency of the vessel while allowing visualization of plaque endpoints, reducing trauma to the vessel walls. This is critical for preserving blood flow and improving surgical outcomes during the removal of atherosclerotic plaque.
How is the Pruitt F3 Carotid Shunt supplied and what are its sterility and usage guidelines?
The device is supplied sterile and is intended for single-use only in controlled surgical environments. Sterility is maintained through manufacturing protocols, ensuring it is safe for immediate use without additional sterilization. Due to its single-use nature, it must not be reused or reprocessed, as this could compromise sterility and patient safety.
What sizes and configurations are available for the Pruitt F3 Carotid Shunt?
The Pruitt F3 Carotid Shunt is available in multiple sizes and configurations, including versions with and without a T-port. The T-port variant provides additional functionality for surgical procedures, while the standard version offers a simpler design. These variations allow surgeons to select the most appropriate shunt for their specific patient needs and procedural requirements.
Does the Pruitt F3 Carotid Shunt require external clamps, and how does it secure placement?
No, the Pruitt F3 Carotid Shunt does not require external clamps for placement. It features occlusion balloons at both ends, which secure the shunt within the vessel and maintain patency. This design minimizes trauma to the vessel walls and simplifies the surgical procedure by reducing the need for additional clamping mechanisms.
What storage and handling protocols should be followed for the Pruitt F3 Carotid Shunt?
The Pruitt F3 Carotid Shunt must be stored and handled according to standard sterile medical device protocols. This includes maintaining the sterile packaging until immediate use, avoiding contamination, and adhering to manufacturer guidelines for shelf life and environmental conditions. Proper storage ensures the device remains effective and safe for its intended single-use application.
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: Pruitt F3® Carotid Shunts | LeMaitre, PDF Pruitt F3® Carotis Shunt Pruitt F3® Carotid Shu - LeMaitre, PDF R4285-00 Rev. A.indd - LeMaitre, PDF Summary of Safety and Clinical Performance Page 1 of 28 Pruitt F3 and ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K051067 | Class II | Active |
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Manufacturer
- Manufacturer
- LeMaitre Vascular, Inc.
Sources (1)
- FDA 510(k) K051067 24 fields · synced Oct 6, 2026