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model 366-12 adaptaid tm step-down adapter
Intermedics
Summary: The Adaptaid TM 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 or adjustment of filters in the inferior vena cava.
FDA Clearance Information
Pathway
510K
Number
K874930 ↗
Decision Date
January 6, 1988
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 January 6, 1988. Manufactured by Intermedics, it is classified as a Class III device under product code DTB.
What It Is
The Adaptaid TM Step-Down Adapter is a specialized medical device designed to assist in the placement or adjustment of inferior vena cava (IVC) filters. These filters are used to prevent pulmonary embolism by capturing blood clots that travel from the lower extremities to the lungs. The adapter facilitates the connection between different components of the filter system, ensuring secure and precise deployment.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is particularly useful in procedures involving the insertion or adjustment of IVC filters in patients at risk of venous thromboembolism, such as those with deep vein thrombosis or a history of pulmonary embolism. The adapter is used in hospital settings, often in catheterization labs or operating rooms, and is essential for ensuring the compatibility of various filter components.
Indications for Use
The FDA indications for the Adaptaid TM Step-Down Adapter involve its use in procedures requiring the placement of IVC filters. It is intended for patients who are at risk of developing blood clots that could lead to pulmonary embolism, particularly when anticoagulation therapy is contraindicated or ineffective.
Practical Considerations
Clinicians should be aware of the compatibility of the adapter with specific IVC filter models. Proper sizing and secure connections are critical to ensure the effectiveness and safety of the procedure. Familiarity with the device's handling and integration into the filter system is essential for optimal performance.
Frequently Asked Questions
What is the Adaptaid TM Step-Down Adapter used for?
It is used to facilitate the placement or adjustment of inferior vena cava (IVC) filters, which help prevent pulmonary embolism.
What specialties typically use this device?
Interventional radiologists and vascular surgeons primarily use this device during procedures involving IVC filters.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring IVC filter placement to prevent pulmonary embolism, especially when 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.