đź“‹ FDA Reference
091 long sheath 70 cm 091 long sheath 80 cm 091 long sheath 90 cm
Inneuro
Summary: The 091 long sheath by Inneuro is a medical device used primarily in venous stenting procedures. It is designed for use by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K172468 ↗
Decision Date
December 6, 2017
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The 091 long sheath received FDA clearance through the 510(k) pathway on December 6, 2017. Manufactured by Inneuro, it is classified as a Class 2 device under product code DQY.
What It Is
The 091 long sheath is a flexible, elongated tube designed to facilitate the delivery of stents and other devices into the venous system. It is available in lengths of 70 cm, 80 cm, and 90 cm, allowing for access to various anatomical sites. The sheath provides a stable conduit for device passage, minimizing trauma to the vessel wall during procedures.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery for procedures involving venous stenting. It is particularly useful in treating conditions like venous obstructions or insufficiencies, where stent placement is necessary to restore proper blood flow. The sheath's design allows for precise navigation and placement in both hospital and outpatient settings.
Indications for Use
The 091 long sheath is indicated for use in patients requiring venous stenting, often due to conditions like chronic venous insufficiency or post-thrombotic syndrome. It aids in the placement of stents to improve venous blood flow.
Practical Considerations
When selecting a sheath size, consider the length needed to reach the target site while maintaining maneuverability. Compatibility with other devices, such as guidewires and stents, is crucial for successful procedures. Proper technique in sheath insertion and navigation can reduce the risk of vessel injury.
Frequently Asked Questions
What is the 091 long sheath used for?
The 091 long sheath is used for facilitating the delivery of stents and other devices into the venous system during interventional procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in procedures involving venous stenting.
What are the FDA-cleared indications?
The device is indicated for use in venous stenting procedures, particularly for conditions requiring improved venous blood flow.
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.