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conquest pta balloon dilatation catheter
C.R. Bard
Summary: The Conquest PTA Balloon Dilatation Catheter is a medical device used primarily for dilating stenotic vessels. It is FDA 510(k) cleared and linked to studies examining radial force distribution and drug-eluting balloon angioplasty.
FDA Clearance Information
Pathway 510K
Number K083657 ↗
Decision Date December 24, 2008
Product Code DQY
Device Class Class 2
Evidence 0 studies
The Conquest PTA Balloon Dilatation Catheter was cleared by the FDA via the 510(k) pathway on December 24, 2008. It is manufactured by C.R. Bard and classified as a Class 2 device under product code DQY.
What It Is
The Conquest PTA Balloon Dilatation Catheter is designed for percutaneous transluminal angioplasty (PTA) to dilate stenotic segments in blood vessels. It is used to restore vessel patency by applying radial force to the vessel walls.
Clinical Applications
This device is commonly used in procedures involving venous stents, particularly in cases where vessel stenosis is present. It is applicable in both peripheral and central vascular interventions.
Evidence Summary
The available literature includes two studies: one experimental study from 2024 examining radial force distribution and another clinical trial on drug-eluting balloon angioplasty for dialysis access. The studies vary in design, including RCT and unknown types.
Reported Outcomes
Published studies report on the radial force exerted by balloon catheters, highlighting differences along the longitudinal axis. However, specific efficacy outcomes are not detailed in the provided evidence.
Safety Profile
Reported complications include potential variations in radial force application, which may affect procedural outcomes. No specific adverse events are detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and lack of detailed outcome data. Further research is needed to establish comprehensive safety and efficacy profiles.
Frequently Asked Questions
What are the clinical indications for Conquest PTA Balloon Dilatation Catheter?
The device is indicated for dilating stenotic segments in blood vessels, often used in conjunction with venous stents.
What outcomes have been reported in clinical studies?
Studies have focused on radial force distribution, but specific clinical outcomes are not detailed in the provided evidence.
What complications have been reported?
Safety data is limited, but variations in radial force application have been noted as a potential concern.
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.