📋 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 ?
510(k)
Number ?
K172468 ↗
Decision Date ?
December 6, 2017
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Percutaneous introduction of compatible catheters and other intravascular devices into the vascular system.
- Use as a conduit for endovascular procedures when access to a distant vascular target is required.
- Use with compatible guidewires, catheters, stents, and related devices according to their labeling and the sheath's instructions for use.
Clinical Applications
- Providing long vascular access during endovascular venous procedures.
- Facilitating delivery of devices used for iliac or central venous stenting when the selected sheath length and inner diameter are appropriate.
- Maintaining a stable conduit for catheter and device exchanges during image-guided vascular intervention.
- Supporting percutaneous access to distant venous targets in interventional radiology and vascular surgery.
Practical Considerations
- The available lengths are 70 cm, 80 cm, and 90 cm; select a length that reaches the target vessel while preserving control and minimizing unnecessary slack.
- Confirm compatibility between the sheath's inner diameter, guidewire, catheter, stent, and any delivery system before use.
- Insertion and navigation should be performed under appropriate imaging guidance using standard sterile vascular-access technique.
- The record provided does not establish MRI safety labeling; consult the current manufacturer instructions for use before MRI exposure.
- Potential contraindications, warnings, and risks include access-site bleeding, infection, vessel injury, thrombosis, embolization, and device malfunction; follow the current instructions for use and clinical judgment.
Procedures that use this device
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.