đź“‹ FDA Reference
Sendero Microcatheter
Summary: The Sendero Microcatheter is a device used for delivering therapeutic agents or devices into the vascular system, primarily in venous stenting procedures. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K231600 ↗
Decision Date ?
November 17, 2023
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Sendero Microcatheter, manufactured by Okami Medical, received FDA 510k clearance (K231600) on November 17, 2023. It is classified as a Class 2 device under product code DQY.
What It Is
The Sendero Microcatheter is a flexible, small-diameter catheter designed to navigate the vascular system. It facilitates the delivery of stents or other therapeutic devices to targeted venous sites. Its design allows for precise control and positioning, which is crucial in minimally invasive vascular procedures.
FDA-Cleared Indications
- For percutaneous access to and navigation within the vascular system during procedures that require catheter-based delivery of therapeutic agents or devices.
- For use in vascular interventions, including procedures involving delivery and positioning of venous stents when compatible with the treatment system and anatomy.
Clinical Applications
- Catheter-based access and navigation during venous stenting procedures.
- Delivery or support of compatible therapeutic devices to a targeted venous location.
- Treatment procedures requiring endovascular access to venous obstructions or narrowed venous segments.
- Use in minimally invasive vascular procedures performed by appropriately trained clinicians.
Practical Considerations
- The available FDA record does not provide complete specifications for the available catheter sizes, lengths, working length, or tip configurations; users should consult the current manufacturer labeling.
- Compatibility with guidewires, introducer sheaths, contrast agents, stent systems, and other devices must be confirmed before use.
- The catheter should be advanced under appropriate imaging guidance with careful attention to vessel anatomy and resistance; excessive force can cause vessel injury or device damage.
- MRI safety is not established by the information provided here. Review the current labeling for MR Safe, MR Conditional, or MR Unsafe status before an MRI examination.
- Contraindications, warnings, and precautions should be taken from the current FDA-cleared labeling and instructions for use rather than inferred from the product category.
Procedures that use this device
Frequently Asked Questions
What is the Sendero Microcatheter used for?
The Sendero Microcatheter is used for delivering stents and other therapeutic devices into the venous system during minimally invasive procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use the Sendero Microcatheter in their procedures.
What are the FDA-cleared indications?
The device is indicated for use in venous stenting procedures, particularly for patients with 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.