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intri24 sheath
Inari Medical
Summary: The intri24 sheath is a medical device used in embolization procedures. It is primarily used for vascular access in interventional radiology. Key evidence is limited and primarily consists of editorial comments and studies unrelated to the device.
FDA Clearance Information
Pathway
510K
Number
K212392 ↗
Decision Date
April 1, 2022
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The intri24 sheath by Inari Medical was cleared through the FDA 510(k) pathway on April 1, 2022. It is classified as a Class 2 device under product code DYB.
What It Is
The intri24 sheath is designed for vascular access during embolization procedures. It facilitates the introduction of interventional devices into the vascular system, aiding in the treatment of vascular conditions.
Clinical Applications
Commonly used in interventional radiology, the intri24 sheath is employed in procedures requiring vascular access, such as embolization. It is particularly useful in scenarios where precise device placement is critical.
Evidence Summary
The available literature includes 10 studies, primarily consisting of editorial comments and unrelated research. The studies span from 2003 to 2023, with limited direct evidence on the intri24 sheath.
Reported Outcomes
Published studies report limited direct outcomes related to the intri24 sheath. The available evidence does not provide specific efficacy findings for this device, as most studies are unrelated or editorial in nature.
Safety Profile
Reported complications include a lack of specific safety data related to the intri24 sheath. The evidence provided does not detail adverse events or complications directly associated with the device.
Evidence Limitations
The evidence base for the intri24 sheath is limited, with most studies being unrelated or editorial comments. There is a need for more targeted research to establish efficacy and safety outcomes specific to this device.
Frequently Asked Questions
What are the clinical indications for intri24 sheath?
The intri24 sheath is indicated for use in embolization procedures requiring vascular access.
What outcomes have been reported in clinical studies?
The available studies do not provide specific outcomes related to the intri24 sheath.
What complications have been reported?
Safety data specific to the intri24 sheath is not detailed in the provided evidence.
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.