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r2p navicross
Terumo Medical
Summary: The r2p Navicross is a catheter device used for navigating through the vascular system, primarily in venous stenting procedures. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K231044 ↗
Decision Date
July 27, 2023
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The r2p Navicross by Terumo Medical was cleared through the FDA 510k pathway on July 27, 2023. It is classified as a Class 2 device under product code DQY.
What It Is
The r2p Navicross is a specialized catheter designed to facilitate the navigation and delivery of therapeutic devices within the vascular system. It features a flexible design that allows for precise maneuverability through complex vascular pathways. This device is particularly useful in procedures requiring the placement of stents in venous systems, offering enhanced control and access for clinicians.
Clinical Applications
The r2p Navicross is commonly used in interventional procedures involving venous stenting, such as treating venous obstructions or insufficiencies. It is employed in hospital settings, often in catheterization labs, by specialists like interventional radiologists and vascular surgeons. The device is suitable for adult patients with conditions requiring venous intervention, providing a reliable tool for accessing difficult-to-reach vascular areas.
Indications for Use
The FDA indications for the r2p Navicross include its use in procedures that require the placement of stents within the venous system. It is intended for patients with venous obstructions or other conditions that necessitate stenting to restore proper blood flow.
Practical Considerations
The r2p Navicross is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard guidewires and stenting systems, making it versatile for use in a range of vascular interventions. Clinicians should be familiar with catheter navigation techniques to optimize the device's performance.
Frequently Asked Questions
What is r2p Navicross used for?
The r2p Navicross is used for navigating and delivering stents in venous stenting procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use the r2p Navicross.
What are the FDA-cleared indications?
The device is indicated for use in venous stenting procedures to treat venous obstructions or insufficiencies.
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.