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the nanostim introducer kit
St. Jude Medical
Summary: The Nanostim Introducer Kit is a medical device used for the introduction of embolization coils. It is primarily used by interventional radiologists and cardiologists to treat conditions requiring vascular embolization.
FDA Clearance Information
Pathway
510K
Number
K160716 ↗
Decision Date
April 14, 2016
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Nanostim Introducer Kit was cleared through the FDA 510(k) pathway on April 14, 2016. Manufactured by St. Jude Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The Nanostim Introducer Kit is designed to facilitate the placement of embolization coils within the vascular system. It consists of a sheath and dilator that provide a conduit for the safe and precise delivery of coils to targeted areas. This device is particularly useful in procedures requiring minimally invasive techniques to manage abnormal blood flow or bleeding.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings for procedures such as treating aneurysms or arteriovenous malformations. It is suitable for use in hospitals and specialized clinics, primarily involving adult patients who require embolization to prevent hemorrhage or reduce blood supply to a tumor.
Indications for Use
The FDA-cleared indications for the Nanostim Introducer Kit involve its use in the delivery of embolization coils to occlude blood vessels. This is typically indicated for patients with vascular abnormalities or those requiring controlled blood flow management.
Practical Considerations
Clinicians should be aware of the compatibility of the introducer kit with various coil sizes and types. Proper technique in handling and placement is crucial to ensure successful outcomes and minimize complications. Familiarity with vascular anatomy and imaging guidance is essential for effective use.
Frequently Asked Questions
What is the Nanostim Introducer Kit used for?
It is used for the introduction of embolization coils to occlude blood vessels in various interventional procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in vascular embolization procedures.
What are the FDA-cleared indications?
The device is indicated for the delivery of embolization coils to occlude blood vessels, managing conditions like aneurysms or vascular malformations.
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.