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vertex tm catheter
Jupiter Endovascular
Summary: The Vertex TM Catheter is a Class 2 medical device used in embolization procedures. It is primarily utilized by interventional radiologists and vascular surgeons for treating vascular abnormalities.
FDA Clearance Information
Pathway
510K
Number
K252027 ↗
Decision Date
September 12, 2025
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Vertex TM Catheter, manufactured by Jupiter Endovascular, received FDA 510k clearance (K252027) on September 12, 2025. It is classified as a Class 2 device under product code DYB.
What It Is
The Vertex TM Catheter is a specialized catheter designed for use in embolization procedures. It facilitates the delivery of embolic agents to target blood vessels, aiding in the occlusion of abnormal vascular structures. This device is particularly useful in treating aneurysms, arteriovenous malformations, and other vascular anomalies.
Clinical Applications
Clinically, the Vertex TM Catheter is employed in interventional radiology and vascular surgery settings. It is used in procedures requiring precise delivery of embolic materials, such as in the treatment of cerebral aneurysms or uterine fibroids. The device is suitable for adult patients with vascular conditions that necessitate embolization.
Indications for Use
The FDA-cleared indications for the Vertex TM Catheter involve its use in embolization procedures to treat vascular abnormalities. It is intended for patients who require targeted occlusion of blood vessels to manage conditions like aneurysms or arteriovenous malformations.
Practical Considerations
The Vertex TM Catheter is available in various sizes to accommodate different vessel diameters. It is compatible with standard embolic agents and requires careful handling to ensure precise placement. Clinicians should be trained in catheter-based techniques for optimal use.
Related Literature
The linked study investigates gender differences in hypoglycemia among adults with type 1 diabetes. It examines the frequency and consequences of level 2 and level 3 hypoglycemia, highlighting the role of gender in these experiences. While not directly related to the Vertex TM Catheter, the study underscores the importance of understanding patient-specific factors in medical management.
Frequently Asked Questions
What is the Vertex TM Catheter used for?
The Vertex TM Catheter is used for embolization procedures to treat vascular abnormalities such as aneurysms and arteriovenous malformations.
What specialties typically use this device?
The Vertex TM Catheter is typically used by interventional radiologists and vascular surgeons.
What are the FDA-cleared indications?
The FDA-cleared indications include use in embolization procedures for the treatment of vascular abnormalities.
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.