đź“‹ FDA Reference
model 366-19 adaptaid adapter sleeve
Intermedics
Summary: The Adaptaid Adapter Sleeve by Intermedics is a medical device used in conjunction with IVC filters. It is primarily used by interventional radiologists and vascular surgeons to facilitate the placement of these filters.
FDA Clearance Information
Pathway 510K
Number K860985 ↗
Decision Date March 31, 1986
Product Code DTB
Device Class Class 3
Evidence 0 studies
The Adaptaid Adapter Sleeve was cleared through the FDA 510(k) pathway on March 31, 1986. Manufactured by Intermedics, it is classified as a Class III device under product code DTB.
What It Is
The Adaptaid Adapter Sleeve is a specialized medical device designed to assist in the placement 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 sleeve ensures a secure and precise fit during the insertion of the filter, enhancing procedural safety and efficacy.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings, particularly in procedures involving patients at risk for pulmonary embolism. It is typically employed in hospital settings, where patients may be undergoing treatment for deep vein thrombosis or other conditions that predispose them to clot formation. The adapter sleeve aids in the accurate deployment of IVC filters, which are often used in patients who cannot tolerate anticoagulation therapy.
Indications for Use
The Adaptaid Adapter Sleeve is indicated for use in patients requiring the placement of an IVC filter, particularly those at risk for pulmonary embolism. It is suitable for patients who have contraindications to anticoagulation or have experienced recurrent embolic events despite medication.
Practical Considerations
The adapter sleeve is designed to be compatible with a range of IVC filter models, ensuring versatility in clinical use. Clinicians should be familiar with the specific sizing and compatibility requirements of the sleeve to ensure optimal performance. Proper technique during insertion is crucial to minimize complications and ensure the filter is securely placed.
Frequently Asked Questions
What is the Adaptaid Adapter Sleeve used for?
It is used to facilitate the placement of inferior vena cava (IVC) filters, which help prevent pulmonary embolism.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in hospital settings.
What are the FDA-cleared indications?
It is indicated for patients requiring IVC filter placement, particularly those at risk for pulmonary embolism and who 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.