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sendero microcatheter
Okami Medical
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 510K
Number K240384 ↗
Decision Date March 8, 2024
Product Code DQY
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.
Clinical Applications
The Sendero Microcatheter is commonly used in endovascular procedures involving venous stenting. It is particularly useful in treating conditions like deep vein thrombosis or chronic venous insufficiency. Interventional radiologists and vascular surgeons use this device in hospital settings, often in catheterization labs, to improve blood flow and alleviate symptoms in patients with venous blockages.
Indications for Use
The FDA-cleared indications for the Sendero Microcatheter involve its use in procedures requiring venous stenting. It is intended for patients with conditions that cause venous obstruction or narrowing, where stent placement can restore adequate blood flow.
Practical Considerations
The Sendero Microcatheter is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard guidewires and stents used in venous interventions. Clinicians should be familiar with catheter manipulation techniques to optimize procedural outcomes.
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.