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acufex tag delivery system
Acufex Microsurgical
Summary: The Acufex Tag Delivery System is a medical device used in uterine fibroid embolization procedures. It is typically used by interventional radiologists to treat patients with symptomatic uterine fibroids.
FDA Clearance Information
Pathway
510K
Number
K953276 ↗
Decision Date
October 5, 1995
Product Code
JDR
Device Class
Class 2
Evidence
0 studies
The Acufex Tag Delivery System was cleared through the FDA 510k pathway on October 5, 1995. Manufactured by Acufex Microsurgical, it is classified as a Class 2 device under the product code JDR.
What It Is
The Acufex Tag Delivery System is designed to assist in the delivery of embolic agents during uterine fibroid embolization procedures. It facilitates precise placement of embolic materials to occlude blood vessels supplying uterine fibroids, thus reducing their size and alleviating symptoms. The system is engineered to provide controlled delivery, enhancing procedural accuracy and patient outcomes.
Clinical Applications
This device is commonly used in interventional radiology settings, particularly for the treatment of women with symptomatic uterine fibroids. It is employed in minimally invasive procedures where embolization is necessary to manage fibroid-related symptoms such as heavy menstrual bleeding or pelvic pain. The device is suitable for use in hospital settings where interventional radiology services are available.
Indications for Use
The FDA-cleared indication for the Acufex Tag Delivery System is for use in uterine fibroid embolization. This procedure is intended for patients experiencing symptoms from uterine fibroids, such as excessive bleeding or discomfort.
Practical Considerations
The device typically comes in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard embolic agents used in uterine fibroid embolization. Clinicians should be familiar with catheter-based techniques to optimize the use of this system.
Frequently Asked Questions
What is the Acufex Tag Delivery System used for?
It is used for delivering embolic agents during uterine fibroid embolization procedures.
What specialties typically use this device?
Interventional radiologists primarily use this device in the treatment of uterine fibroids.
What are the FDA-cleared indications?
The device is indicated for use in uterine fibroid embolization to treat symptomatic uterine fibroids.
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.