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sendero microcatheter
Okami Medical
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 510K
Number K231600 ↗
Decision Date November 17, 2023
Product Code DQY
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.
Clinical Applications
This microcatheter is commonly used in interventional radiology and vascular surgery settings for procedures involving venous stenting. It is particularly useful in treating conditions like venous insufficiency or blockages. The device is suitable for use in hospitals and specialized outpatient centers, serving adult and geriatric patient populations.
Indications for Use
The FDA-cleared indications for the Sendero Microcatheter include its use in procedures requiring venous stenting. It is intended for patients with venous obstructions or other conditions that necessitate the placement of a stent to restore proper blood flow.
Practical Considerations
The Sendero Microcatheter is available in various sizes to accommodate different vascular anatomies. It is compatible with standard guidewires and stent delivery systems. Clinicians should be familiar with catheter manipulation techniques to ensure successful navigation and deployment.
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.