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intri26 introducer sheath
Inari Medical
Summary: The intri26 introducer sheath by Inari Medical is a Class 2 medical device cleared by the FDA for use in embolization procedures. Key evidence highlights its role in mechanical thrombectomy and revascularization techniques.
FDA Clearance Information
Pathway
510K
Number
K252508 ↗
Decision Date
December 17, 2025
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The intri26 introducer sheath received FDA clearance through the 510(k) pathway on December 17, 2025. It is manufactured by Inari Medical and classified as a Class 2 device.
What It Is
The intri26 introducer sheath is a medical device designed to facilitate the insertion of catheters and other instruments into the vascular system. It is primarily used in embolization procedures and mechanical thrombectomy for acute ischemic stroke.
Clinical Applications
Commonly, the intri26 introducer sheath is used in scenarios requiring vascular access, such as during mechanical thrombectomy for stroke or revascularization procedures for large-vessel occlusions.
Evidence Summary
The available literature includes 10 peer-reviewed studies, encompassing various study types such as RCTs, prospective, and retrospective studies, published between 2022 and 2024.
Reported Outcomes
Published studies report that the intri26 introducer sheath is effective in facilitating mechanical thrombectomy and revascularization procedures. It has been used successfully in treating acute ischemic stroke and common carotid artery occlusions.
Safety Profile
Reported complications include radial artery occlusion and accidental placement in artificial grafts. These events highlight the importance of careful handling and placement during procedures.
Evidence Limitations
Current evidence is limited by the small number of studies and the need for more comprehensive trials to better understand long-term outcomes and safety profiles. Further research is needed to explore additional clinical applications.
Frequently Asked Questions
What are the clinical indications for intri26 introducer sheath?
The intri26 introducer sheath is indicated for use in embolization procedures and mechanical thrombectomy for acute ischemic stroke.
What outcomes have been reported in clinical studies?
Studies have reported successful use in mechanical thrombectomy and revascularization, particularly in acute ischemic stroke and large-vessel occlusions.
What complications have been reported?
Safety data indicate complications such as radial artery occlusion and accidental placement in artificial grafts.
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.