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agiltrac 035 peripheral dilatation catheter
Guidant
Summary: The Agiltrac 035 is a peripheral dilatation catheter used primarily for venous stent procedures. It is FDA-cleared and supported by multiple studies, though specific outcomes and safety data are limited in the provided evidence.
FDA Clearance Information
Pathway
510K
Number
K022738 ↗
Decision Date
September 13, 2002
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Agiltrac 035 Peripheral Dilatation Catheter was cleared by the FDA via the 510(k) pathway on September 13, 2002. It is manufactured by Guidant and classified as a Class 2 device.
What It Is
The Agiltrac 035 is a peripheral dilatation catheter designed for use in venous stenting procedures. It functions by dilating vessels to facilitate stent placement, aiding in the treatment of vascular obstructions.
Clinical Applications
This device is commonly used in procedures involving venous stents, particularly in cases where vessel dilation is necessary to ensure proper stent deployment and vascular patency.
Evidence Summary
The available literature includes 8 studies, covering a range of study types such as RCTs and case series. These studies span from 2020 to 2023, providing insights into the device's clinical applications.
Reported Outcomes
Published studies report varied outcomes related to the use of peripheral dilatation catheters, though specific efficacy data for the Agiltrac 035 is not detailed in the provided evidence. General findings suggest effectiveness in maintaining vessel patency during stent procedures.
Safety Profile
Reported complications include potential for acute recoil and vascular complications, as noted in related studies. However, specific safety data for the Agiltrac 035 is not detailed in the provided evidence.
Evidence Limitations
The evidence provided lacks specific data on the Agiltrac 035, with no direct studies on its outcomes or safety. Further research is needed to establish comprehensive efficacy and safety profiles for this device.
Frequently Asked Questions
What are the clinical indications for Agiltrac 035 Peripheral Dilatation Catheter?
The device is indicated for use in venous stenting procedures requiring vessel dilation.
What outcomes have been reported in clinical studies?
General findings suggest effectiveness in maintaining vessel patency, though specific outcomes for Agiltrac 035 are not detailed.
What complications have been reported?
Reported complications include potential for acute recoil and vascular complications, but specific data for Agiltrac 035 is not provided.
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.