đź“‹ FDA Reference
INTRI24 Introducer Sheath 52-101
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 ?
510(k)
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.
FDA-Cleared Indications
- Intended to provide vascular access during interventional procedures.
- Used to facilitate the introduction of catheters, guidewires and other intravascular devices.
- May be used in procedures involving embolization coils and other embolic materials, according to the applicable labeling.
Clinical Applications
- Providing arterial or venous access for catheter-based embolization procedures.
- Maintaining a stable access route while embolization coils or other devices are delivered.
- Supporting image-guided endovascular procedures that require passage of compatible guidewires and catheters.
Practical Considerations
- The 52-101 designation identifies the listed device configuration; clinicians should confirm the sheath’s inner diameter, usable length and compatibility with the planned guidewires and catheters.
- Access is typically obtained through a percutaneous puncture, commonly in the femoral or another appropriate artery or vein, using imaging guidance.
- Potential complications include bleeding, hematoma, infection, vessel injury, thrombosis, embolization and contrast-related complications.
- MRI safety and conditions should be confirmed in the current manufacturer’s instructions for use; do not assume MRI compatibility from the sheath name alone.
- The sheath is a sterile, single-use device and should not be reused or resterilized.
Procedures that use this device
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.