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model 366-20 adaptaid step-down adapter
Intermedics
Summary: The Adaptaid Step-Down Adapter is a medical device used in conjunction with IVC filters. It is primarily utilized by interventional radiologists and vascular surgeons to facilitate the placement of these filters in patients requiring venous thromboembolism prevention.
FDA Clearance Information
Pathway
510K
Number
K861176 ↗
Decision Date
April 29, 1986
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Adaptaid Step-Down Adapter by Intermedics was cleared through the FDA 510(k) pathway on April 29, 1986. It is classified as a Class III medical device under product code DTB.
What It Is
The Adaptaid Step-Down Adapter is a specialized connector used in the deployment of inferior vena cava (IVC) filters. These filters are designed to prevent pulmonary embolism by capturing blood clots that travel from the lower extremities to the lungs. The adapter ensures compatibility between different components of the filter system, allowing for precise placement and secure anchoring within the vena cava.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is particularly relevant for patients at high risk of venous thromboembolism, such as those with deep vein thrombosis or those undergoing major surgery. The adapter facilitates the safe and effective deployment of IVC filters, which are crucial in preventing life-threatening pulmonary embolisms.
Indications for Use
The FDA indications for the Adaptaid Step-Down Adapter involve its use in conjunction with IVC filters to prevent pulmonary embolism. It is intended for patients who are at risk of blood clots traveling to the lungs, especially those who cannot be managed with anticoagulation therapy alone.
Practical Considerations
When using the Adaptaid Step-Down Adapter, clinicians should ensure compatibility with the specific IVC filter system being used. Proper technique is essential for successful deployment, and practitioners should be familiar with the sizing and insertion process to minimize complications.
Frequently Asked Questions
What is the Adaptaid Step-Down Adapter used for?
It is used to facilitate the placement of IVC filters in patients at risk of 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 with IVC filters to prevent pulmonary embolism in patients at risk of venous thromboembolism.
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.