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intri24 introducer sheath 52-101
Inari Medical
Summary: The intri24 introducer sheath is a medical device used for vascular access during procedures such as embolization. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K233646 ↗
Decision Date
December 12, 2023
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The intri24 introducer sheath by Inari Medical was cleared via the FDA 510k pathway on December 12, 2023. It is classified as a Class 2 device under product code DYB.
What It Is
The intri24 introducer sheath is a medical device designed to facilitate vascular access during interventional procedures. It consists of a flexible tube that is inserted into a blood vessel, allowing other instruments to be passed through it. This device is crucial in minimizing trauma to the vessel and providing a stable access point for various interventions.
Clinical Applications
The intri24 introducer sheath is commonly used in procedures involving embolization, where coils or other materials are placed within blood vessels to block blood flow to an area. It is frequently utilized in interventional radiology and cardiology settings, particularly for patients requiring precise vascular access. This device is suitable for use in both hospital and outpatient settings.
Indications for Use
The FDA indications suggest that the intri24 introducer sheath is intended for use in procedures requiring vascular access, such as those involving embolization coils. It is suitable for patients who need interventions to manage conditions like aneurysms or vascular malformations.
Practical Considerations
The intri24 introducer sheath is available in various sizes to accommodate different vessel diameters. It is compatible with standard guidewires and catheters, making it versatile for a range of procedures. Clinicians should ensure proper sizing and technique to minimize complications.
Frequently Asked Questions
What is intri24 introducer sheath used for?
The intri24 introducer sheath is used for vascular access during procedures such as embolization, allowing instruments to be introduced into blood vessels.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use the intri24 introducer sheath in their procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring vascular access, such as those involving embolization coils, to manage conditions like aneurysms.
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.