đź“‹ FDA Reference
Odyssey Micro Catheter
Heraeus Medical Components, LLC
Product: Odyssey Micro Catheter — all models and sizes
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 ?
510(k)
Number ?
K170664 ↗
Decision Date ?
November 9, 2017
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Percutaneous catheter use for accessing or navigating the vascular system during an endovascular procedure.
- Use as an accessory catheter with compatible interventional devices according to the cleared labeling.
- The supplied FDA summary does not provide enough detail to confirm a specific venous-stenting indication.
Clinical Applications
- Catheter-based access and navigation in peripheral venous interventions.
- Delivery or support of compatible devices during endovascular treatment, when included in the device-specific labeling.
- Use during selected venous stenting procedures when the catheter configuration and labeling are appropriate.
Practical Considerations
- Confirm the catheter's available diameter, length, tip configuration and guidewire compatibility before the procedure.
- Use fluoroscopic or other appropriate imaging guidance and maintain sterile technique during vascular access and navigation.
- The supplied record does not establish MRI safety; verify MR Safe, MR Conditional or MR Unsafe status in the current product labeling before MRI.
- Potential risks of percutaneous catheterization include bleeding, hematoma, infection, vessel injury, thrombosis, embolization and contrast-related complications.
- Do not use when the patient or intended procedure is incompatible with the current device labeling, materials, size, access route or required guidewire.
Procedures that use this device
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.