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model 366-30 adaptaid tm adapter sleeve
Intermedics
Summary: The Adaptaid TM Adapter Sleeve is a medical device used in conjunction with IVC filters to aid in their placement or function. It is typically utilized by interventional radiologists or vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K873921 ↗
Decision Date
December 3, 1987
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Adaptaid TM Adapter Sleeve was cleared through the FDA 510k pathway on December 3, 1987. Manufactured by Intermedics, it is classified as a Class III device.
What It Is
The Adaptaid TM Adapter Sleeve is a specialized component designed to work with inferior vena cava (IVC) filters. It serves as an adapter to ensure proper fit and function of the filter within the vascular system. This device is crucial for maintaining the stability and positioning of IVC filters, which are used to prevent pulmonary embolism by trapping blood clots.
Clinical Applications
The Adaptaid TM Adapter Sleeve is primarily used in interventional radiology and vascular surgery settings. It is employed during procedures involving the placement of IVC filters, particularly in patients at risk for venous thromboembolism. The device is used in hospitals and specialized clinics, often in patients who cannot tolerate anticoagulation therapy.
Indications for Use
The device is indicated for use in patients requiring the placement of an IVC filter, often due to a high risk of blood clots traveling to the lungs. It is particularly useful in patients who have contraindications to anticoagulation therapy.
Practical Considerations
The Adaptaid TM Adapter Sleeve is designed to be compatible with specific IVC filter models. Clinicians should ensure compatibility with the filter being used and follow standard techniques for insertion and placement. Proper sizing and alignment are crucial for optimal performance.
Frequently Asked Questions
What is Adaptaid TM Adapter Sleeve used for?
It is used to assist in the placement and function of IVC filters, which prevent blood clots from reaching the lungs.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device during procedures involving IVC filters.
What are the FDA-cleared indications?
The device is indicated for use in patients needing IVC filter placement, especially those at risk for pulmonary embolism and unable to take anticoagulants.
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.