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fustar steerable introducers
Lifetech Scientific (Shenzhen)
Summary: Fustar Steerable Introducers are used in venous stent procedures. They are FDA-cleared and have been studied for their novel application in vascular occlusion. Key evidence includes a study on their use in a porcine model.
FDA Clearance Information
Pathway
510K
Number
K100184 ↗
Decision Date
February 14, 2011
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Fustar Steerable Introducers were cleared by the FDA via the 510(k) pathway on February 14, 2011. Manufactured by Lifetech Scientific, they are classified as Class 2 devices.
What It Is
The Fustar Steerable Introducers are medical devices designed to facilitate the placement of venous stents. They feature a steerable mechanism that aids in precise navigation and deployment within the vascular system.
Clinical Applications
These introducers are commonly used in procedures requiring the placement of venous stents, particularly in scenarios where precise navigation is critical. They are instrumental in endovascular interventions.
Evidence Summary
The literature includes two studies, one published in 2016 and another in 2025. These studies explore the device's application in vascular occlusion and novel percutaneous techniques, respectively.
Reported Outcomes
Published studies report the Fustar Steerable Introducers as effective in facilitating vascular occlusion in a porcine model. The device's unique design allows for improved navigation and deployment in complex vascular procedures.
Safety Profile
Reported complications include potential limitations due to the size and rigidity of the delivery sheath, as noted in the porcine model study. No specific adverse events were detailed in the available literature.
Evidence Limitations
The evidence is limited to two studies, with one being a preclinical study in a porcine model. Further research is needed to establish efficacy and safety in human clinical settings.
Frequently Asked Questions
What are the clinical indications for Fustar Steerable Introducers?
The device is indicated for use in procedures requiring venous stent placement, particularly where precise navigation is necessary.
What outcomes have been reported in clinical studies?
Studies have reported effective vascular occlusion in a porcine model, highlighting the device's navigational capabilities.
What complications have been reported?
Safety data indicate potential issues with the size and rigidity of the delivery sheath, though specific adverse events were not detailed.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.