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thinline sheath introducer
Inneuro
Summary: The thinline sheath introducer by Inneuro is a medical device used primarily in interventional radiology and neurology for vascular access during embolization procedures. It is typically used by specialists such as interventional radiologists and neurosurgeons.
FDA Clearance Information
Pathway
510K
Number
K232260 ↗
Decision Date
September 27, 2023
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The thinline sheath introducer was cleared through the FDA 510(k) pathway on September 27, 2023. It is manufactured by Inneuro and classified as a Class 2 device under product code DYB.
What It Is
The thinline sheath introducer is a medical device designed to facilitate the insertion of catheters or other instruments into the vascular system. It is typically used in minimally invasive procedures to provide a stable and secure access point. The device's thin profile allows for reduced trauma to the vessel and improved patient comfort during procedures.
Clinical Applications
This device is commonly used in procedures involving the placement of embolization coils, which are used to treat aneurysms or arteriovenous malformations. It is frequently utilized in interventional radiology and neurosurgery settings, particularly in hospitals with specialized vascular intervention units. The typical patient population includes those with vascular abnormalities requiring precise and controlled intervention.
Indications for Use
The FDA-cleared indications for the thinline sheath introducer include its use in procedures requiring vascular access for the placement of embolization coils. It is intended for patients with conditions such as aneurysms or other vascular malformations.
Practical Considerations
The thinline sheath introducer is available in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with standard catheter systems and requires careful handling to ensure proper placement and minimize vessel trauma. Clinicians should be familiar with the device's specifications and insertion techniques to optimize outcomes.
Frequently Asked Questions
What is the thinline sheath introducer used for?
It is used for vascular access during procedures involving the placement of embolization coils, such as treating aneurysms.
What specialties typically use this device?
Interventional radiologists and neurosurgeons commonly use this device in vascular intervention procedures.
What are the FDA-cleared indications?
The device is indicated for use in providing vascular access for embolization coil placement in patients with vascular abnormalities.
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.