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odyssey micro catheter
Heraeus Medical Components
Summary: The Odyssey Micro Catheter is a medical device used primarily in venous stenting procedures. It is utilized by interventional radiologists and vascular surgeons to navigate through the vascular system.
FDA Clearance Information
Pathway
510K
Number
K170664 ↗
Decision Date
November 9, 2017
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Odyssey Micro Catheter was cleared through the FDA 510k pathway on November 9, 2017. Manufactured by Heraeus Medical Components, it is classified as a Class 2 device under product code DQY.
What It Is
The Odyssey Micro Catheter is a small, flexible catheter designed to navigate the vascular system, particularly in venous stenting procedures. It allows for precise delivery of stents and other therapeutic devices within the veins. Its design facilitates maneuverability through complex vascular anatomy, making it a valuable tool in minimally invasive procedures.
Clinical Applications
Commonly used in interventional radiology and vascular surgery, the Odyssey Micro Catheter is employed in procedures involving venous stenting, such as treating venous obstructions or insufficiencies. It is particularly useful in settings requiring precise navigation and placement of stents in the venous system, often in patients with chronic venous diseases.
Indications for Use
The FDA indications suggest that the Odyssey Micro Catheter is intended for use in procedures requiring venous stenting. This includes patients with conditions like venous obstructions or chronic venous insufficiency, where stenting can help restore proper blood flow.
Practical Considerations
The Odyssey Micro Catheter is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard guidewires and stents used in venous interventions. Clinicians should be familiar with catheter navigation techniques to optimize its use.
Frequently Asked Questions
What is the Odyssey Micro Catheter used for?
It is used for navigating the vascular system during venous stenting procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
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.