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aviator peripheral dilatation catheter
Guidant
Summary: The Aviator Peripheral Dilatation Catheter is a medical device used primarily for dilating peripheral arteries. It is FDA 510k cleared and linked to studies focusing on arterial disease treatment. Key evidence highlights its application in venous-stents.
FDA Clearance Information
Pathway
510K
Number
K010831 ↗
Decision Date
June 13, 2001
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Aviator Peripheral Dilatation Catheter, manufactured by Guidant, received FDA clearance through the 510k pathway on June 13, 2001. It is classified as a Class 2 device under product code DQY.
What It Is
The Aviator Peripheral Dilatation Catheter is designed to facilitate the dilation of peripheral arteries. It is used in clinical settings to improve blood flow in patients with arterial blockages, particularly in the context of venous-stents.
Clinical Applications
This catheter is commonly used in procedures involving the treatment of peripheral arterial disease, especially in cases requiring the placement of stents. It is utilized in interventional cardiology and vascular surgery to enhance blood flow and support stent deployment.
Evidence Summary
The available literature includes five studies, primarily focusing on peripheral arterial disease and related interventions. These studies are registered on clinical trial platforms, though specific details on sample sizes and outcomes are not provided.
Reported Outcomes
Published studies report on the effectiveness of the Aviator Peripheral Dilatation Catheter in enhancing arterial patency and supporting stent placement. However, specific efficacy metrics are not detailed in the provided evidence.
Safety Profile
Reported complications include procedural risks typical of catheter-based interventions, though specific adverse events are not detailed in the provided studies. Further research is needed to fully characterize the safety profile.
Evidence Limitations
The evidence base is limited by a lack of detailed outcome data and specific safety findings. Further research is necessary to establish comprehensive efficacy and safety profiles, as well as to explore long-term outcomes.
Frequently Asked Questions
What are the clinical indications for aviator peripheral dilatation catheter?
The device is indicated for use in procedures requiring the dilation of peripheral arteries, particularly in the context of venous-stents.
What outcomes have been reported in clinical studies?
Studies report on the catheter's role in improving arterial patency and supporting stent placement, though specific outcomes are not detailed.
What complications have been reported?
Reported complications include general procedural risks, but specific adverse events are not detailed in the provided evidence.
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.