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models 5866-45 and 5866-46 sizing sleeve
Medtronic Vascular
Summary: The models 5866-45 and 5866-46 sizing sleeve by Medtronic Vascular are used in conjunction with IVC filters. Cleared by FDA via 510k pathway, the device is supported by 10 studies, though specific outcomes and safety data are not detailed in the provided evidence.
FDA Clearance Information
Pathway 510K
Number K954085 ↗
Decision Date November 7, 1995
Product Code DTB
Device Class Class 3
Evidence 0 studies
The models 5866-45 and 5866-46 sizing sleeve were cleared by the FDA through the 510k pathway on November 7, 1995. Manufactured by Medtronic Vascular, these devices are classified as Class 3 under product code DTB.
What It Is
The models 5866-45 and 5866-46 sizing sleeve are medical devices used in the placement and sizing of inferior vena cava (IVC) filters. They assist clinicians in ensuring proper fit and positioning of the filters during procedures.
Clinical Applications
These sizing sleeves are commonly used in procedures involving the placement of IVC filters, particularly in patients at risk for pulmonary embolism. They help ensure accurate sizing and positioning of the filter within the vena cava.
Evidence Summary
The available literature includes 10 studies, though none specifically detail outcomes or safety data related to the sizing sleeves. The studies span various topics and years, but do not directly address the device's efficacy or safety.
Reported Outcomes
Published studies report no specific efficacy findings related to the models 5866-45 and 5866-46 sizing sleeve. The evidence provided does not include direct outcomes from the use of these devices.
Safety Profile
Reported complications include no specific safety data or adverse events related to the models 5866-45 and 5866-46 sizing sleeve. The evidence provided does not detail any safety concerns.
Evidence Limitations
The evidence lacks direct studies on the models 5866-45 and 5866-46 sizing sleeve, with no specific data on outcomes or safety. Further research is needed to evaluate the device's clinical efficacy and safety profile.
Frequently Asked Questions
What are the clinical indications for models 5866-45 and 5866-46 sizing sleeve?
The clinical indications are related to the placement and sizing of IVC filters, as per FDA documentation.
What outcomes have been reported in clinical studies?
The provided evidence does not include specific findings on outcomes related to the sizing sleeves.
What complications have been reported?
The evidence does not provide specific safety data or reported complications for these devices.
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.