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kdl micro catheter
Shanghai Kindly Medical Instruments
Summary: The KDL Micro Catheter is a medical device used for delivering therapeutic agents or devices in vascular procedures. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K201706 ↗
Decision Date
July 22, 2021
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The KDL Micro Catheter was cleared through the FDA 510k pathway on July 22, 2021. Manufactured by Shanghai Kindly Medical Instruments, it is classified as a Class 2 device under product code DQY.
What It Is
The KDL Micro Catheter is a small, flexible catheter designed for navigating the vascular system to deliver therapeutic agents or devices. It is typically used in minimally invasive procedures, allowing clinicians to reach small or tortuous vessels with precision. The catheter's design facilitates access to difficult-to-reach areas, making it a valuable tool in endovascular interventions.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures such as embolization, delivery of stents, or infusion of medications. It is particularly useful in treating conditions like aneurysms, arteriovenous malformations, or peripheral vascular disease. The catheter is often employed in hospital settings, especially in catheterization labs or interventional suites.
Indications for Use
The FDA indications for the KDL Micro Catheter include its use in vascular procedures where precise delivery of agents or devices is required. It is suitable for patients needing interventions in small or complex vascular territories.
Practical Considerations
The KDL Micro Catheter is available in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with standard guidewires and can be used in conjunction with other endovascular tools. Clinicians should be familiar with catheter navigation techniques to optimize its use.
Frequently Asked Questions
What is KDL Micro Catheter used for?
The KDL Micro Catheter is used for delivering therapeutic agents or devices in vascular procedures, such as embolization or stent placement.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device in endovascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in vascular procedures requiring precise delivery of therapeutic agents or devices, particularly in small or complex vessels.
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.