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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 specific procedures.
FDA Clearance Information
Pathway
510K
Number
K871625 ↗
Decision Date
May 21, 1987
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Adaptaid TM Step-Down Adapter by Intermedics was cleared via the FDA 510k pathway on May 21, 1987. 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 interface with inferior vena cava (IVC) filters. It serves as a connector or adapter that allows for the step-down of certain components during vascular procedures. This device is critical in ensuring compatibility and seamless integration of various vascular instruments.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings, particularly during procedures involving the placement or retrieval of IVC filters. It is essential for patients requiring long-term management of venous thromboembolism, especially those who cannot tolerate anticoagulation therapy. The adapter ensures that the procedural tools are compatible and function effectively during these interventions.
Indications for Use
The FDA indications suggest that this device is intended for use in patients who require IVC filter placement or retrieval. It is particularly relevant for individuals at risk of pulmonary embolism who are contraindicated for anticoagulant therapy.
Practical Considerations
The Adaptaid TM Step-Down Adapter typically comes in various sizes to accommodate different IVC filter systems. Clinicians should ensure compatibility with existing vascular instruments and be familiar with the procedural techniques required for its use.
Frequently Asked Questions
What is the Adaptaid TM Step-Down Adapter used for?
It is used to facilitate the placement or retrieval of IVC filters by ensuring compatibility between different vascular instruments.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device during procedures involving IVC filters.
What are the FDA-cleared indications?
The device is indicated for use in patients needing IVC filter placement or retrieval, particularly those at risk of pulmonary embolism who cannot use anticoagulants.
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.