📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Introduction and delivery of embolization coils into the vascular system.
- Placement of embolization coils to occlude, or block, blood vessels when vascular embolization is indicated.
Clinical Applications
- Catheter-based delivery of embolization coils for intentional vascular occlusion.
- Embolization procedures performed by interventional radiologists or vascular surgeons.
- Treatment of selected vascular abnormalities when coil embolization is part of the planned procedure.
Practical Considerations
- The device must be selected in a size and configuration appropriate for the target vessel and the embolization coil being used.
- Accurate placement requires fluoroscopic or other appropriate vascular imaging guidance and knowledge of vascular anatomy.
- The device is intended for trained clinicians experienced in catheter-based vascular procedures.
- MRI safety and conditional-use information should be confirmed in the current device labeling; this record alone does not establish that the device is MR safe.
- Risks and contraindications depend on the procedure, access site, target vessel, embolic material and the patient's medical condition.
Procedures that use this device
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.