đź“‹ FDA Reference
Sendero Microcatheter
Product: Sendero — all models and sizes
Summary: The Sendero Microcatheter is a medical device used in endovascular procedures, primarily by interventional radiologists and vascular surgeons for venous stenting. It assists in navigating complex vascular anatomy.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K240384 ↗
Decision Date ?
March 8, 2024
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Sendero Microcatheter, manufactured by Okami Medical, was cleared via the FDA 510(k) pathway on March 8, 2024. It is a Class 2 device under product code DQY.
What It Is
The Sendero Microcatheter is a flexible, small-diameter catheter designed for navigating the vascular system. It is used to deliver therapeutic agents or devices, such as stents, to specific sites within the venous system. Its design allows for precise control and maneuverability in complex vascular anatomy, making it an essential tool in minimally invasive procedures.
FDA-Cleared Indications
- Used percutaneously to access and navigate the vascular system during endovascular procedures.
- Used to deliver therapeutic agents or interventional devices to a selected vascular location, according to the device labeling.
- May be used as part of procedures involving treatment of venous vascular disease when catheter-based delivery is required.
Clinical Applications
- Catheter-based access and navigation within the venous system.
- Delivery of devices or therapeutic materials during venous interventions.
- Support for endovascular procedures involving venous obstruction or narrowing when a compatible catheter is needed.
- Use during venous stenting procedures as part of the catheter and guidewire system.
Practical Considerations
- The available catheter sizes, lengths, distal-tip configuration and required guidewire compatibility should be confirmed in the current manufacturer instructions for use.
- The catheter is manipulated under fluoroscopic or other intravascular imaging guidance by trained clinicians.
- MRI safety and conditional-use requirements must be verified from the current product labeling; do not assume the device is MRI safe.
- Potential complications are those associated with percutaneous vascular catheterization, including bleeding, vascular injury, infection, thrombosis, embolization and contrast-related reactions.
- Contraindications, warnings and compatibility with specific stents, guidewires, contrast agents or therapeutic materials should be checked in the current labeling before use.
Procedures that use this device
Frequently Asked Questions
What is the Sendero Microcatheter used for?
The Sendero Microcatheter is used for delivering stents and therapeutic agents in venous stenting procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use the Sendero Microcatheter.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring venous stenting to treat conditions like venous 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.