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model 366-27 adaptaid tm step-down adapter
Intermedics
Summary: The Adaptaid TM Step-Down Adapter by Intermedics is a medical device used in the context of IVC filters. It is primarily utilized by interventional radiologists and vascular surgeons to facilitate specific procedures.
FDA Clearance Information
Pathway
510K
Number
K864048 ↗
Decision Date
November 3, 1986
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Adaptaid TM Step-Down Adapter was cleared through the FDA 510k pathway on November 3, 1986. 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 catching blood clots. The adapter serves as a connector or transition piece, ensuring compatibility between different components or systems during the procedure.
Clinical Applications
This device is commonly used in procedures involving the placement of IVC filters, particularly in patients at risk of venous thromboembolism. It is typically employed in hospital settings, especially in interventional radiology suites or vascular surgery departments. The primary patient population includes those with contraindications to anticoagulation therapy or those who have experienced recurrent embolic events despite anticoagulation.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures involving IVC filters. Clinically, it is used in patients who require protection from pulmonary embolism, particularly when anticoagulation is not an option.
Practical Considerations
The Adaptaid TM Step-Down Adapter is designed to ensure compatibility between various IVC filter systems. Clinicians should be aware of the specific sizing and compatibility requirements of the adapter with the IVC filter systems they are using. Proper technique and familiarity with the device are essential for successful outcomes.
Frequently Asked Questions
What is the Adaptaid TM Step-Down Adapter used for?
It is used to facilitate the placement or adjustment 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?
The device is indicated for use in procedures involving 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.