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embol-x introducer model cf00200
Embol-X
Summary: The Embol-X Introducer Model CF00200 is a medical device used for introducing embolization coils into the vascular system. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K002973 ↗
Decision Date
April 26, 2001
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Embol-X Introducer Model CF00200 was cleared through the FDA 510(k) pathway on April 26, 2001. It is manufactured by Embol-X and classified as a Class 2 device under product code DYB.
What It Is
The Embol-X Introducer Model CF00200 is a specialized catheter system designed to facilitate the delivery of embolization coils into the vascular system. It consists of an introducer sheath and a delivery mechanism that ensures precise placement of coils to occlude blood vessels. This device is essential in procedures aimed at controlling bleeding or reducing blood flow to certain areas.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is particularly useful in procedures such as treating aneurysms, arteriovenous malformations, or other vascular abnormalities where embolization is required. The device is suitable for adult patients and can be used in both elective and emergency situations.
Indications for Use
The FDA indications for the Embol-X Introducer Model CF00200 involve its use in delivering embolization coils to occlude blood vessels. This is typically indicated for patients with vascular conditions that require reduced blood flow to certain areas, such as aneurysms or vascular tumors.
Practical Considerations
The device 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 vascular anatomy and have experience in catheter-based interventions.
Frequently Asked Questions
What is the Embol-X Introducer Model CF00200 used for?
It is used for introducing embolization coils into the vascular system to occlude blood vessels.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for delivering embolization coils to occlude blood vessels in patients with vascular conditions requiring reduced blood flow.
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.