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itc bunji platinum embolization coil
Interventional Therapeutics
Summary: The itc bunji platinum embolization coil is a medical device used to occlude blood vessels, commonly in interventional radiology. It is primarily used by interventional radiologists to treat aneurysms and other vascular conditions.
FDA Clearance Information
Pathway
510K
Number
K925523 ↗
Decision Date
March 23, 1993
Product Code
HCG
Device Class
Class 2
Evidence
0 studies
The itc bunji platinum embolization coil was cleared through the FDA 510k pathway on March 23, 1993. Manufactured by Interventional Therapeutics, it is classified as a Class 2 device under product code HCG.
What It Is
The itc bunji platinum embolization coil is a device designed to occlude or block blood vessels. It is made from platinum, which is radiopaque, allowing for precise placement under imaging guidance. The coil is deployed into the target vessel via a catheter, where it induces clot formation and vessel occlusion, effectively stopping blood flow to the area.
Clinical Applications
This device is commonly used in interventional radiology procedures to treat cerebral aneurysms, arteriovenous malformations, and other vascular abnormalities. It is typically used in hospital settings, particularly in catheterization labs, and is suitable for adult and pediatric patients requiring embolization therapy. The coil's flexibility and radiopacity make it ideal for navigating complex vascular anatomy.
Indications for Use
The FDA-cleared indications for the itc bunji platinum embolization coil include use in patients requiring vascular occlusion. This is often applicable in cases of aneurysms or vascular malformations where blood flow needs to be controlled or stopped.
Practical Considerations
The itc bunji platinum embolization coil comes in various sizes to accommodate different vessel diameters. It is compatible with standard microcatheters used in embolization procedures. Clinicians should be familiar with coil deployment techniques to ensure accurate placement and optimal patient outcomes.
Frequently Asked Questions
What is itc bunji platinum embolization coil used for?
It is used to occlude blood vessels in procedures like treating aneurysms or vascular malformations.
What specialties typically use this device?
Interventional radiologists primarily use this device in vascular and neurovascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring vascular occlusion, such as those with aneurysms or 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.