📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Vascular access for the placement of embolization coils.
- Use as an introducer sheath to facilitate the insertion of compatible catheters or instruments into the vascular system during an indicated procedure.
Clinical Applications
- Providing vascular access during embolization procedures involving embolization coils.
- Supporting catheter-based treatment of intracranial aneurysms when embolization coils are placed.
- Supporting catheter-based treatment of selected vascular malformations when embolization coils are placed.
Practical Considerations
- The appropriate sheath size depends on the access vessel, the catheter or device being used, and the procedure.
- It should be used with compatible catheters, guidewires, and other instruments according to the manufacturer's instructions for use.
- Insertion and removal require image guidance and careful technique to reduce bleeding, dissection, perforation, thrombosis, and other vascular complications.
- MRI safety and conditional-use information must be confirmed in the current product labeling; this record does not establish that the device is MRI safe.
- Contraindications, warnings, and precautions should be reviewed in the manufacturer's labeling. General concerns include unsuitable vascular access, uncontrolled bleeding risk, and inability to safely navigate the intended vessel.
Procedures that use this device
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.