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Temporary Limb Salvage Shunt

FDA 510(k)

Class II (US FDA 510(k))

510(k) K070323

by Vascutek Ltd

Identifiers

510(k) Number
K070323 FDA 510(k)
FDA Product Code
DXC 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 Temporary Limb Salvage Shunt is an expanded polytetrafluoroethylene (ePTFE) vascular prosthesis classified as a temporary bypass shunt. It is designed to restore blood flow through damaged major vessels in trauma surgery, providing critical perfusion to salvage limbs at risk of ischemia. This device is intended for short-term use during emergency interventions where immediate vascular reconstruction is required. Its structure mimics natural vessels to maintain patency and reduce occlusion risks during temporary circulation support.

This shunt is supplied as a sterile, single-use device for intraoperative application in trauma or vascular emergency settings. It is intended for use in procedures where traditional grafting is impractical due to time constraints or patient instability. The device is regulated under FDA 510(k) clearance (K070323) and falls under the Cardiovascular (CV) advisory committee classification. Storage and handling follow standard sterile surgical protocols, with no MRI compatibility restrictions specified. Its dimensions and sizing align with common vascular graft standards for emergency limb salvage procedures.

Frequently asked questions

What is the Temporary Limb Salvage Shunt used for?

The Temporary Limb Salvage Shunt is designed to restore blood flow through damaged major vessels during trauma surgery. It acts as a temporary bypass to maintain perfusion to limbs at risk of ischemia when immediate vascular reconstruction is impractical due to time constraints or patient instability. Its structure mimics natural vessels to minimize occlusion risks while providing critical support until definitive treatment can be performed.

How is the Temporary Limb Salvage Shunt supplied and prepared for use?

The shunt is supplied as a sterile, single-use device, pre-packaged for intraoperative application in trauma or vascular emergency settings. It adheres to standard sterile surgical protocols, ensuring readiness for immediate deployment without additional preparation beyond sterile handling. This design eliminates the need for reprocessing or reuse, reducing infection risks in high-pressure environments.

Is the Temporary Limb Salvage Shunt intended for long-term or short-term use?

This shunt is explicitly designed for short-term use during emergency interventions. Its purpose is to provide temporary circulation support until definitive vascular reconstruction can be completed. The material and construction prioritize stability and patency only for the critical window when traditional grafting is impractical, such as in unstable trauma patients.

What sizing and dimensions are available for the Temporary Limb Salvage Shunt?

The shunt’s dimensions align with common vascular graft standards for emergency limb salvage procedures, though exact sizes are not specified in the provided data. It is engineered to match typical major vessel diameters encountered in trauma cases, ensuring compatibility with standard surgical techniques. For precise sizing, clinicians should refer to the device’s packaging or manufacturer documentation during procurement.

How should the Temporary Limb Salvage Shunt be stored, and are there any special handling requirements?

Storage follows standard sterile surgical protocols to maintain integrity until use. The shunt should be kept in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. No MRI compatibility restrictions are specified, but adherence to sterile field practices is critical to prevent contamination. Always check expiration dates and ensure the packaging remains uncompromised before use.

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: TEMPORARY LIMB SALVAGE SHUNT (K070323) — FDA 510(k) | Innolitics, PDF K070323 - Temporary Limb Salvage Shunt, PDF 3;)3 SUMMARY VASCUTEK TEMPORARY LIMB SALAVE SHUNT Page 1 of 3

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Vascutek Ltd
FDA Applicant
Vascutek, Ltd.

Sources (1)

  • FDA 510(k) K070323 24 fields · synced Oct 1, 2026