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norton jugular kits
Norton Performance Plastics
Summary: Norton Jugular Kits are medical devices used for vascular access and embolization procedures, primarily by interventional radiologists and surgeons. They are designed to aid in the delivery of embolization coils to treat vascular abnormalities.
FDA Clearance Information
Pathway
510K
Number
K820581 ↗
Decision Date
March 18, 1982
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Norton Jugular Kits were cleared through the FDA 510(k) pathway on March 18, 1982. Manufactured by Norton Performance Plastics, this Class 2 device is categorized under product code DYB.
What It Is
The Norton Jugular Kits are specialized medical devices used for vascular access, specifically designed to facilitate the delivery of embolization coils. These kits typically include a catheter and other components necessary for accessing the jugular vein and deploying coils to occlude blood vessels. The device is constructed from biocompatible materials to ensure patient safety during procedures.
Clinical Applications
Norton Jugular Kits are commonly used in interventional radiology and vascular surgery for procedures involving embolization of vascular abnormalities such as aneurysms or arteriovenous malformations. They are utilized in hospital settings, particularly in catheterization labs, and are suitable for adult and pediatric patients requiring vascular intervention. The kits enable precise delivery of embolization coils to targeted vascular sites.
Indications for Use
The FDA-cleared indications for Norton Jugular Kits involve their use in embolization procedures to treat vascular conditions. These devices are intended for patients with conditions that require the occlusion of blood vessels to prevent abnormal blood flow.
Practical Considerations
Norton Jugular Kits come in various sizes to accommodate different patient anatomies and procedural requirements. They are compatible with standard embolization coils and require careful handling to ensure precise placement. Clinicians should be trained in vascular access techniques to optimize outcomes.
Frequently Asked Questions
What is Norton Jugular Kits used for?
Norton Jugular Kits are used for vascular access and embolization procedures to treat vascular abnormalities by delivering embolization coils.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use Norton Jugular Kits in hospital settings.
What are the FDA-cleared indications?
The kits are indicated for use in embolization procedures to occlude blood vessels in patients with vascular conditions.
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.