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model 366-13 adaptaid step down adapter
Intermedics
Summary: The Adaptaid Step Down Adapter is a medical device used in conjunction with IVC filters, primarily by interventional radiologists and vascular surgeons. It facilitates the connection of different components in medical procedures.
FDA Clearance Information
Pathway
510K
Number
K864326 ↗
Decision Date
January 16, 1987
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Adaptaid Step Down Adapter by Intermedics was cleared through the FDA 510k pathway on January 16, 1987. It is classified as a Class III device under product code DTB.
What It Is
The Adaptaid Step Down Adapter is a specialized connector used in medical procedures involving inferior vena cava (IVC) filters. It allows for the seamless integration of various medical components, ensuring compatibility and functionality during procedures. This device is crucial in maintaining the integrity of the vascular access system, facilitating the safe and effective deployment of IVC filters.
Clinical Applications
This adapter 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 ensuring compatibility between different catheter systems and filter devices, thereby enhancing procedural efficiency and patient safety. The primary patient population includes individuals at risk of pulmonary embolism, often those with contraindications to anticoagulation therapy.
Indications for Use
The Adaptaid Step Down Adapter is indicated for use in procedures involving IVC filters, which are typically used in patients who require protection from pulmonary embolism but cannot undergo anticoagulation therapy. It ensures the proper connection of medical devices during these procedures.
Practical Considerations
Clinicians should be aware of the specific sizing and compatibility requirements when using the Adaptaid Step Down Adapter. It is important to ensure that all components are compatible to avoid procedural complications. Familiarity with the device's integration into existing systems is crucial for optimal use.
Frequently Asked Questions
What is the Adaptaid Step Down Adapter used for?
It is used to connect different components in procedures involving IVC filters, ensuring compatibility and functionality.
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?
It is indicated for use in procedures involving IVC filters, particularly for patients who need protection from pulmonary embolism but cannot use anticoagulation therapy.
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.