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intropeel
Menlo Care
Summary: The intropeel is a medical device used for embolization procedures, commonly utilized by interventional radiologists to occlude blood vessels. It is designed for use in various vascular interventions.
FDA Clearance Information
Pathway
510K
Number
K930801 ↗
Decision Date
September 22, 1993
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The intropeel was cleared via the FDA 510(k) pathway on September 22, 1993, by Menlo Care. It is classified as a Class II device under product code DYB.
What It Is
The intropeel is an embolization coil, a device used to block blood flow in specific blood vessels. It is typically made of metal and designed to be delivered through a catheter to the target site. Once deployed, the coil induces clot formation, effectively occluding the vessel. This device is crucial in managing conditions such as aneurysms or arteriovenous malformations.
Clinical Applications
Intropeel is commonly used in interventional radiology and vascular surgery. It is employed in procedures to treat aneurysms, control bleeding, or reduce blood flow to tumors. The device is suitable for use in hospital settings, particularly in catheterization labs, and is often used in adult and pediatric patients requiring vascular intervention.
Indications for Use
The FDA indications for intropeel include its use in embolization procedures to occlude blood vessels. It is intended for patients with conditions such as aneurysms or vascular malformations that require controlled blood flow reduction.
Practical Considerations
Intropeel comes in various sizes to accommodate different vessel diameters, and it is compatible with standard catheter systems. Clinicians should be trained in catheter-based interventions to ensure proper deployment and positioning of the coil.
Frequently Asked Questions
What is intropeel used for?
Intropeel is used for embolization procedures to occlude blood vessels in conditions like aneurysms and vascular malformations.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use intropeel in their procedures.
What are the FDA-cleared indications?
Intropeel is indicated for embolization procedures to occlude blood vessels, particularly in cases of aneurysms and 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.