đź“‹ FDA Reference
medtronic model 5866-45 sizing sleeve
Medtronic Vascular
Summary: The Medtronic Model 5866-45 Sizing Sleeve is a medical device used primarily in the placement of inferior vena cava (IVC) filters. It is utilized by vascular surgeons and interventional radiologists to ensure proper sizing and placement of IVC filters in patients requiring prevention of pulmonary embolism.
FDA Clearance Information
Pathway
510K
Number
K890644 ↗
Decision Date
May 31, 1989
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Medtronic Model 5866-45 Sizing Sleeve was cleared through the FDA's 510(k) pathway on May 31, 1989. Manufactured by Medtronic Vascular, it is classified as a Class III device under product code DTB.
What It Is
The Medtronic Model 5866-45 Sizing Sleeve is a specialized tool designed to assist in the accurate sizing of the inferior vena cava during the placement of IVC filters. It functions by providing a precise measurement of the vessel diameter, ensuring that the selected filter fits properly and functions effectively. This device is crucial in preventing complications associated with incorrect filter sizing, such as migration or inadequate filtration.
Clinical Applications
This sizing sleeve is commonly used in procedures involving the placement of IVC filters, which are typically performed in hospital settings by vascular surgeons and interventional radiologists. It is particularly relevant for patients at risk of pulmonary embolism, such as those with deep vein thrombosis or contraindications to anticoagulation therapy. The device is used to ensure that the filter is appropriately sized for the patient's anatomy, thereby optimizing the procedure's success and safety.
Indications for Use
The FDA indications for the Medtronic Model 5866-45 Sizing Sleeve focus on its role in the placement of IVC filters. It is intended for use in patients who require protection against pulmonary embolism, particularly when anticoagulation is not an option or has failed.
Practical Considerations
Clinicians should be aware of the typical sizing ranges compatible with the Medtronic Model 5866-45 Sizing Sleeve to ensure accurate measurements. It is important to follow the manufacturer's guidelines for use to prevent complications. The device is compatible with a variety of IVC filters, but confirming compatibility with specific filter models is recommended.
Frequently Asked Questions
What is the Medtronic Model 5866-45 Sizing Sleeve used for?
It is used for accurately sizing the inferior vena cava during the placement of IVC filters to prevent pulmonary embolism.
What specialties typically use this device?
Vascular surgeons and interventional radiologists commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in sizing the inferior vena cava for the placement of IVC filters in patients at risk of pulmonary embolism.
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.