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model 366-10 adaptaid step-down adapter
Intermedics
Summary: The Model 366-10 Adaptaid Step-Down Adapter by Intermedics is a medical device used in conjunction with IVC filters. It is primarily utilized by interventional radiologists and vascular surgeons to facilitate procedures involving inferior vena cava filters.
FDA Clearance Information
Pathway
510K
Number
K861110 ↗
Decision Date
April 23, 1986
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model 366-10 Adaptaid Step-Down Adapter was cleared through the FDA 510(k) pathway on April 23, 1986. Manufactured by Intermedics, it is classified as a Class III device under product code DTB.
What It Is
The Model 366-10 Adaptaid Step-Down Adapter is a specialized medical device designed to interface with inferior vena cava (IVC) filters. It serves as a connector or adapter that helps in the deployment or retrieval of IVC filters, which are used to prevent pulmonary embolism by trapping blood clots. This device ensures compatibility between different components of the IVC filter system, facilitating smooth procedural workflows.
Clinical Applications
This adapter is commonly used in procedures involving the placement or retrieval of IVC filters, which are typically performed in interventional radiology suites or operating rooms. It is crucial in scenarios where there is a need to adapt or modify existing filter systems to ensure proper fit and function. The device is used in patients at risk of venous thromboembolism, particularly those who cannot be managed with anticoagulation therapy alone.
Indications for Use
The FDA indications for this device involve its use in conjunction with IVC filters. It is intended for patients who require the placement of an IVC filter to prevent pulmonary embolism, especially in cases where anticoagulation is contraindicated or ineffective.
Practical Considerations
The Model 366-10 Adaptaid Step-Down Adapter is typically compatible with a range of IVC filter systems, but clinicians should verify compatibility with specific filter models prior to use. Proper technique in connecting and securing the adapter is essential to ensure procedural success and patient safety.
Frequently Asked Questions
What is the Model 366-10 Adaptaid Step-Down Adapter used for?
It is used to connect and facilitate the deployment or retrieval of inferior vena cava filters.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use with IVC filters to prevent pulmonary embolism in patients where anticoagulation is not suitable.
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.