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navicross 0 018
Terumo
Summary: The Navicross 0 018 by Terumo is a medical device used in venous stenting procedures. It is primarily utilized by interventional radiologists and vascular surgeons to treat venous obstructions.
FDA Clearance Information
Pathway
510K
Number
K173799 ↗
Decision Date
March 29, 2018
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Navicross 0 018 was cleared through the FDA 510(k) pathway on March 29, 2018. Manufactured by Terumo, it is classified as a Class 2 medical device under product code DQY.
What It Is
The Navicross 0 018 is a guidewire support catheter designed to facilitate the placement of stents in venous systems. It features a flexible, torqueable design that aids in navigating complex venous anatomy. The device is used to improve access and delivery of therapeutic devices in the treatment of venous obstructions.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is particularly useful in procedures involving the placement of venous stents to treat conditions such as deep vein thrombosis or chronic venous insufficiency. The Navicross 0 018 is suitable for adult patients with venous obstructions requiring endovascular intervention.
Indications for Use
The FDA indications suggest that the Navicross 0 018 is intended for use in patients with venous obstructions requiring stenting. It is designed to assist in the delivery and placement of stents within the venous system.
Practical Considerations
The Navicross 0 018 is typically available in various lengths to accommodate different anatomical requirements. It is compatible with standard stenting systems and should be used by clinicians familiar with endovascular techniques. Proper sizing and technique are crucial for optimal performance and patient outcomes.
Frequently Asked Questions
What is Navicross 0 018 used for?
The Navicross 0 018 is used to facilitate the placement of venous stents in patients with venous obstructions.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in endovascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in the placement of stents within the venous system to treat obstructions.
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.