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sendero max delivery catheter
Okami Medical
Summary: The Sendero Max Delivery Catheter is a medical device used to deliver venous stents. It is typically used by interventional radiologists and vascular surgeons in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K242644 ↗
Decision Date
December 20, 2024
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Sendero Max Delivery Catheter by Okami Medical was cleared through the FDA 510k pathway on December 20, 2024. It is a Class 2 device under product code DQY.
What It Is
The Sendero Max Delivery Catheter is a specialized catheter designed for the precise delivery of venous stents. It facilitates the placement of stents within the venous system, ensuring accurate deployment. The device is engineered to navigate the vascular anatomy with ease, providing clinicians with a reliable tool for stent delivery.
Clinical Applications
This device is commonly used in procedures involving the placement of venous stents, particularly in cases of venous obstruction or insufficiency. Interventional radiologists and vascular surgeons utilize it in hospital catheterization labs to treat conditions such as deep vein thrombosis or chronic venous insufficiency. It is suitable for adult patients requiring venous stenting.
Indications for Use
The FDA indications for the Sendero Max Delivery Catheter include its use in the delivery of venous stents to treat conditions like venous obstructions. It is intended for patients who require stent placement to restore proper venous blood flow.
Practical Considerations
The Sendero Max Delivery Catheter is compatible with a range of stent sizes, allowing for flexibility in various clinical scenarios. Clinicians should be familiar with catheter navigation techniques to optimize stent placement. It is important to ensure compatibility with the chosen stent system.
Frequently Asked Questions
What is the Sendero Max Delivery Catheter used for?
The Sendero Max Delivery Catheter is used for delivering venous stents to treat venous obstructions or insufficiencies.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for the delivery of venous stents 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.