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aft allograft filler tube
Musculoskeletal Transplant Foundation
Summary: The AFT Allograft Filler Tube is a medical device used in embolization procedures, primarily by interventional radiologists. It is designed to aid in the treatment of vascular abnormalities.
FDA Clearance Information
Pathway
510K
Number
K060161 ↗
Decision Date
March 21, 2006
Product Code
MBP
Device Class
Class 2
Evidence
0 studies
The AFT Allograft Filler Tube was cleared through the FDA 510(k) pathway on March 21, 2006. Manufactured by the Musculoskeletal Transplant Foundation, it is classified as a Class 2 device under product code MBP.
What It Is
The AFT Allograft Filler Tube is a specialized medical device used in embolization procedures, which involve the intentional blockage of blood vessels. It consists of microspheres made from allograft material, which are delivered to the target site via a catheter. This device is designed to occlude blood vessels, thereby reducing blood flow to specific areas, such as tumors or vascular malformations.
Clinical Applications
This device is commonly used in interventional radiology settings for procedures such as uterine fibroid embolization or the treatment of arteriovenous malformations. It is particularly useful in cases where reducing blood supply can help manage or shrink abnormal tissue growths. Patients who benefit from this device typically include those with benign tumors, such as fibroids, or those with vascular anomalies.
Indications for Use
The FDA indications for the AFT Allograft Filler Tube involve its use in embolization procedures to occlude blood vessels. This is particularly relevant for patients with conditions that benefit from reduced blood flow, such as certain tumors or vascular malformations.
Practical Considerations
When using the AFT Allograft Filler Tube, clinicians should consider the size and compatibility of the microspheres with the target vessels. Proper catheter selection and technique are crucial for effective delivery and placement of the device. Familiarity with embolization procedures is essential for optimal outcomes.
Frequently Asked Questions
What is the AFT Allograft Filler Tube used for?
It is used for embolization procedures to occlude blood vessels, often in the treatment of tumors or vascular malformations.
What specialties typically use this device?
Interventional radiologists primarily use this device in settings such as hospitals and specialized clinics.
What are the FDA-cleared indications?
The device is indicated for use in embolization procedures to block blood vessels, aiding in the treatment of conditions like tumors and vascular anomalies.
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.