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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
K161102 ↗
Decision Date
May 19, 2016
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Nanostim Introducer Kit by St. Jude Medical was cleared through the FDA's 510(k) pathway on May 19, 2016. It is classified as a Class 2 device under product code DYB.
What It Is
The Nanostim Introducer Kit is a specialized medical device designed to facilitate the delivery of embolization coils into blood vessels. It consists of an introducer sheath and associated components, allowing for precise placement of coils. This device is crucial in procedures aimed at occluding blood vessels to prevent or control bleeding, or to cut off blood supply to certain areas, such as tumors.
Clinical Applications
This device is commonly used in interventional radiology and cardiology, particularly in procedures involving vascular embolization. It is utilized in settings such as hospitals and specialized clinics, often in patients requiring treatment for aneurysms, arteriovenous malformations, or tumors. The device is suitable for a wide range of patient populations, including those with complex vascular conditions.
Indications for Use
The FDA indications for the Nanostim Introducer Kit involve its use in the placement of embolization coils. It is intended for patients who require vascular embolization to manage conditions like aneurysms or to reduce blood flow to tumors.
Practical Considerations
The Nanostim Introducer Kit typically comes in various sizes to accommodate different vascular anatomies. It is compatible with standard embolization coils and requires careful handling to ensure accurate placement. Clinicians should be familiar with the vascular anatomy and the specific technique for coil deployment.
Frequently Asked Questions
What is the Nanostim Introducer Kit used for?
It is used for the introduction of embolization coils in vascular procedures to occlude blood vessels.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for the placement of embolization coils in vascular embolization procedures.
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.