đź“‹ FDA Reference
model 366-09 adaptaid adapter sleeve
Intermedics
Summary: The Adaptaid Adapter Sleeve by Intermedics is a medical device used in conjunction with IVC filters. It is primarily utilized by interventional radiologists and vascular surgeons to facilitate the placement and stability of these filters.
FDA Clearance Information
Pathway
510K
Number
K860986 ↗
Decision Date
March 31, 1986
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Adaptaid Adapter Sleeve was cleared through the FDA 510k pathway on March 31, 1986. Manufactured by Intermedics, it is classified as a Class 3 medical device under product code DTB.
What It Is
The Adaptaid Adapter Sleeve is a specialized component designed to assist in the deployment of inferior vena cava (IVC) filters. It serves as an interface between the filter and the delivery system, ensuring secure placement and reducing the risk of migration. This device is crucial in procedures aiming to prevent pulmonary embolism by capturing blood clots before they reach the lungs.
Clinical Applications
The Adaptaid Adapter Sleeve is commonly used in interventional radiology and vascular surgery settings. It is particularly relevant in procedures involving patients at high risk for venous thromboembolism, such as those with deep vein thrombosis or post-surgical immobility. The device is used in hospitals and specialized clinics where IVC filter placement is performed.
Indications for Use
The device is indicated for use in patients requiring the placement of an IVC filter to prevent pulmonary embolism. It is suitable for individuals who have contraindications to anticoagulation therapy or have experienced recurrent embolic events despite medication.
Practical Considerations
The Adaptaid Adapter Sleeve is designed to be compatible with a range of IVC filter systems. Clinicians should ensure proper sizing and secure attachment to the filter delivery system to optimize performance. Familiarity with the specific technique for deploying the sleeve is essential for successful outcomes.
Frequently Asked Questions
What is the Adaptaid Adapter Sleeve used for?
It is used to assist in the placement and stabilization of IVC filters, which help prevent pulmonary embolism.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for patients needing IVC filter placement to prevent pulmonary embolism, especially when anticoagulation is not an option.
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.