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nanostim introducer kit
St. Jude Medical
Summary: The Nanostim Introducer Kit is a medical device used for the introduction of embolization coils in vascular procedures. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K140793 ↗
Decision Date
December 17, 2014
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Nanostim Introducer Kit was cleared through the FDA 510(k) pathway on December 17, 2014. It is manufactured by St. Jude Medical and classified as a Class II device under product code DYB.
What It Is
The Nanostim Introducer Kit is designed to facilitate the delivery of embolization coils into the vascular system. It consists of a sheath and dilator that allow for precise placement of coils to occlude blood vessels, typically to prevent hemorrhage or reduce blood flow to a particular area. This device is essential in minimally invasive procedures where vascular access is required.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings for procedures such as treating aneurysms or arteriovenous malformations. It is used in hospitals and specialized clinics, often in patients requiring embolization to control bleeding or reduce blood supply to tumors. The kit is suitable for adult patients who need precise vascular interventions.
Indications for Use
The FDA-cleared indications for the Nanostim Introducer Kit involve its use in introducing embolization coils into the vascular system. This is typically indicated for patients with conditions requiring targeted vascular occlusion, such as aneurysms or abnormal blood vessel formations.
Practical Considerations
The Nanostim Introducer Kit is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard embolization coils and requires careful handling to ensure accurate placement. Clinicians should be familiar with vascular access techniques and the specific requirements of the procedure being performed.
Frequently Asked Questions
What is the Nanostim Introducer Kit used for?
It is used for the introduction of embolization coils into the vascular system to occlude blood vessels.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in vascular procedures.
What are the FDA-cleared indications?
It is indicated for the introduction of embolization coils into the vascular system for conditions requiring vascular occlusion.
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.