đź“‹ FDA Reference
acs funnel introducer
Advanced Cardiovascular Systems
Summary: The ACS Funnel Introducer is a medical device used primarily in interventional radiology and cardiology for the introduction of embolization coils. It is typically used by specialists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K875158 ↗
Decision Date
May 31, 1988
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The ACS Funnel Introducer was cleared through the FDA 510(k) pathway on May 31, 1988. Manufactured by Advanced Cardiovascular Systems, it is classified as a Class 2 device under product code DYB.
What It Is
The ACS Funnel Introducer is a specialized catheter designed to facilitate the insertion of embolization coils into blood vessels. It features a funnel-shaped tip that aids in the precise placement of coils, which are used to occlude blood vessels in various therapeutic procedures. This device is crucial in ensuring the safe and effective delivery of embolic materials during minimally invasive procedures.
Clinical Applications
Commonly used in interventional radiology and cardiology, the ACS Funnel Introducer is employed in procedures requiring vascular embolization, such as treating aneurysms or arteriovenous malformations. It is particularly useful in settings where precise delivery of embolic agents is critical, often involving patients with vascular abnormalities or hemorrhagic conditions.
Indications for Use
The device is indicated for use in patients requiring embolization procedures to occlude blood vessels. This includes conditions like aneurysms, arteriovenous malformations, or other vascular abnormalities where controlled blood flow is necessary.
Practical Considerations
The ACS Funnel Introducer typically comes in various sizes to accommodate different vessel diameters. It is compatible with standard embolization coils and requires careful handling to ensure accurate placement. Clinicians should be familiar with catheterization techniques to optimize its use.
Frequently Asked Questions
What is the ACS Funnel Introducer used for?
It is used for the introduction of embolization coils into blood vessels during vascular embolization procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in hospital settings.
What are the FDA-cleared indications?
It is indicated for use in embolization procedures to occlude blood vessels, such as in treating 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.