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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 ?
510(k)
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.
FDA-Cleared Indications
- Used in conjunction with an IVC filter during filter placement.
- Used to assist with sizing and positioning an IVC filter within the inferior vena cava.
Clinical Applications
- Sizing an IVC filter before deployment.
- Supporting positioning of an IVC filter in the inferior vena cava.
- Use during percutaneous IVC filter placement procedures.
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.
Practical Considerations
- The record identifies models 5866-45 and 5866-46; the appropriate model should be selected according to the compatible IVC filter system and procedural requirements.
- The sizing sleeve is an accessory used with an IVC filter and is not itself the filter or an independent embolic-protection device.
- Use requires imaging guidance and should be performed by clinicians familiar with IVC anatomy and filter-placement techniques.
- The available record does not provide MRI-safety labeling, specific contraindications, or detailed compatibility information; consult the current manufacturer labeling before use.
- The device is intended for procedural use rather than long-term implantation and should be handled according to the applicable sterile-device instructions.
Procedures that use this device
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.