📊 Evidence-Based Reference
Modification to Attain Prevail 6228cth80 Steerable Catheter Set
Summary: The modification to attain prevail 6228cth80 steerable catheter set is a device used in venous-stent procedures. It is FDA 510k cleared and supported by 7 studies, though specific outcomes and safety data are not detailed in the provided evidence.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K082670 ↗
Decision Date ?
December 4, 2008
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared through the FDA 510k pathway on December 4, 2008. It is manufactured by Medtronic and classified as a Class 2 device under product code DQY.
What It Is
The modification to attain prevail 6228cth80 steerable catheter set is designed for use in venous-stent procedures. It allows for precise navigation and placement of stents within venous structures, enhancing procedural accuracy.
FDA-Cleared Indications
- Percutaneous catheterization and navigation within the venous system.
- Use in interventional procedures requiring steerable catheter access for treatment or device placement.
- Use as part of procedures involving venous stent placement, when consistent with the device's labeling and instructions for use.
Clinical Applications
- Catheter access and navigation through central veins.
- Steerable catheter positioning during iliac or central venous stenting.
- Guiding or supporting endovascular treatment of venous obstruction when the catheter is compatible with the planned procedure.
- Venographic imaging or intraprocedural access when performed according to the device labeling.
Evidence Summary
The available literature consists of 7 studies, though none directly address the device's efficacy or safety. The studies span various years and topics, but specific data on the device's performance are not provided.
Reported Outcomes
Published studies report no specific efficacy findings related to the modification to attain prevail 6228cth80 steerable catheter set. The evidence provided does not include direct outcomes from clinical use of this device.
Safety Profile
Reported complications include no specific safety data related to the device. The evidence provided does not detail adverse events or complications from the use of this catheter set.
Evidence Limitations
The evidence lacks direct studies on the device's efficacy and safety, highlighting a gap in specific clinical data. Further research is needed to establish comprehensive outcomes and safety profiles.
Practical Considerations
- The specific catheter dimensions, working length, tip configuration, guidewire compatibility, and maximum allowable pressure should be confirmed in the current manufacturer instructions for use.
- Use requires fluoroscopic or other appropriate imaging guidance and trained personnel familiar with percutaneous venous catheterization.
- MRI safety and conditional requirements should be verified in the current labeling; this record alone does not establish that the catheter is MR safe or MR conditional.
- Potential contraindications and precautions include venous access-site infection, inability to safely obtain vascular access, contrast allergy when contrast is used, and bleeding or anticoagulation concerns.
- The catheter is a procedural device and is generally removed after the intervention; it is not intended to remain implanted unless the labeling specifically states otherwise.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for modification to attain prevail 6228cth80 steerable catheter set?
The device is indicated for use in venous-stent procedures, providing enhanced navigation and placement capabilities.
What outcomes have been reported in clinical studies?
The provided evidence does not include specific findings on outcomes related to this device.
What complications have been reported?
The evidence does not provide specific safety data or reported complications for this device.
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.