đź“‹ FDA Reference
itc bunji platinum embolization coil
Interventional Therapeutics
Summary: The itc bunji platinum embolization coil is a medical device used to occlude blood vessels during embolization procedures. It is typically used by interventional radiologists and neurosurgeons to treat aneurysms and other vascular abnormalities.
FDA Clearance Information
Pathway
510K
Number
K925876 ↗
Decision Date
April 15, 1993
Product Code
HCG
Device Class
Class 2
Evidence
0 studies
The itc bunji platinum embolization coil was cleared by the FDA through the 510(k) pathway on April 15, 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 blood vessels. It consists of a platinum coil that is deployed into a vessel to induce clot formation, thereby blocking blood flow. This mechanism is particularly useful in treating aneurysms and other vascular malformations by preventing rupture or reducing blood supply to targeted areas.
Clinical Applications
Embolization coils like the itc bunji are commonly used in interventional radiology and neurosurgery. They are employed in the treatment of cerebral aneurysms, arteriovenous malformations, and other vascular conditions. These procedures are typically performed in a hospital setting, often in a catheterization lab, and are used in both emergency and elective scenarios.
Indications for Use
The itc bunji platinum embolization coil is indicated for use in patients with aneurysms or other vascular abnormalities where blood flow needs to be reduced or stopped. This includes conditions like brain aneurysms, where the risk of rupture can be mitigated by embolization.
Practical Considerations
When using the itc bunji coil, clinicians should consider the size and shape of the vessel to ensure proper fit and occlusion. Compatibility with existing catheter systems is crucial, and practitioners should be familiar with the deployment technique to optimize outcomes.
Frequently Asked Questions
What is itc bunji platinum embolization coil used for?
It is used to occlude blood vessels in the treatment of aneurysms and other vascular abnormalities.
What specialties typically use this device?
Interventional radiologists and neurosurgeons typically use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring vascular occlusion, such as those with aneurysms or arteriovenous 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.