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advance micro 14 ultra low profile balloon dilatation catheter model pta3
Cook
Summary: The Advance Micro 14 Ultra Low Profile Balloon Dilatation Catheter by Cook is a device used primarily for venous stent procedures. It is FDA 510(k) cleared with evidence from 10 studies supporting its use.
FDA Clearance Information
Pathway
510K
Number
K122940 ↗
Decision Date
March 19, 2013
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Advance Micro 14 Ultra Low Profile Balloon Dilatation Catheter was cleared through the FDA 510(k) pathway on March 19, 2013. It is manufactured by Cook and classified as a Class 2 device.
What It Is
The device is a balloon dilatation catheter designed for use in venous stent procedures. It features an ultra-low profile to facilitate access and navigation through the vascular system.
Clinical Applications
Commonly used in procedures requiring venous stenting, the catheter assists in dilating vessels to allow for stent placement. It is particularly useful in cases where vessel access is challenging.
Evidence Summary
The literature includes 10 studies, primarily focusing on the device's application in venous stenting. These studies span a range of publication years, providing a comprehensive overview of its clinical utility.
Reported Outcomes
Published studies report that the Advance Micro 14 Ultra Low Profile Balloon Dilatation Catheter effectively facilitates venous stent placement with high success rates. The device's design allows for improved navigation and access in complex vascular scenarios.
Safety Profile
Reported complications include minimal adverse events, with studies indicating a low incidence of device-related complications. The catheter's design minimizes the risk of vessel trauma during procedures.
Evidence Limitations
Current evidence is limited by the small sample sizes and the lack of randomized controlled trials. Further research is needed to establish long-term outcomes and comparative effectiveness with other devices.
Frequently Asked Questions
What are the clinical indications for Advance Micro 14 Ultra Low Profile Balloon Dilatation Catheter?
The device is indicated for use in venous stent procedures, particularly in cases requiring vessel dilation for stent placement.
What outcomes have been reported in clinical studies?
Studies report high success rates in stent placement with effective vessel dilation and minimal complications.
What complications have been reported?
Safety data indicate a low incidence of complications, primarily related to vessel trauma, which are minimized by the device's design.
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.