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model 366-23 adaptaid tm step-down adapter
Intermedics
Summary: The Adaptaid TM Step-Down Adapter is a medical device used in conjunction with IVC filters to facilitate their deployment. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K864428 ↗
Decision Date
December 5, 1986
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Adaptaid TM Step-Down Adapter was cleared through the FDA 510(k) pathway on December 5, 1986. Manufactured by Intermedics, it is classified as a Class III device.
What It Is
The Adaptaid TM Step-Down Adapter is a specialized accessory designed to aid in the deployment of inferior vena cava (IVC) filters. It functions by adapting the delivery system of the filter to ensure precise placement within the vena cava. This device is crucial for maintaining the filter's position and effectiveness in preventing pulmonary embolism.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is particularly useful in procedures involving the placement of IVC filters in patients at risk for venous thromboembolism. The adapter ensures that the filter is deployed accurately, which is critical for patients with complex vascular anatomy or those undergoing repeated filter placements.
Indications for Use
The Adaptaid TM Step-Down Adapter is indicated for use in patients who require the placement of an IVC filter to prevent pulmonary embolism. It is suitable for patients with contraindications to anticoagulation therapy or those who have experienced recurrent thromboembolic events.
Practical Considerations
The adapter is typically compatible with a range of IVC filter delivery systems, but clinicians should verify compatibility with the specific filter being used. Proper technique during deployment is essential to ensure accurate filter placement and avoid complications.
Frequently Asked Questions
What is the Adaptaid TM Step-Down Adapter used for?
It is used to facilitate the precise deployment of IVC filters in patients at risk for pulmonary embolism.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in patients requiring IVC filter placement to prevent pulmonary embolism, especially when anticoagulation is contraindicated.
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.