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9 french large lumen triguide plus guiding catheter
Scimed Life Systems
Summary: The 9 French Large Lumen Triguide Plus Guiding Catheter is a device used primarily in venous stenting procedures. It is FDA 510(k) cleared and supported by 10 studies, though specific outcomes and safety data are limited.
FDA Clearance Information
Pathway
510K
Number
K934988 ↗
Decision Date
January 14, 1994
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on January 14, 1994. It is manufactured by Scimed Life Systems and classified as a Class 2 medical device.
What It Is
The 9 French Large Lumen Triguide Plus Guiding Catheter is designed for use in venous stenting procedures. It facilitates the delivery of stents and other therapeutic devices to the target site within the venous system.
Clinical Applications
This catheter is commonly used in interventional cardiology and radiology for procedures involving the placement of venous stents. It is particularly useful in scenarios requiring precise navigation and delivery of therapeutic devices.
Evidence Summary
The available literature includes a mix of study types, such as case reports and retrospective analyses, with a total of 10 studies. The studies span from 2001 to 2024, though specific data on outcomes and safety are sparse.
Reported Outcomes
Published studies report limited specific outcomes related to the use of the 9 French Large Lumen Triguide Plus Guiding Catheter. The evidence primarily consists of case reports and retrospective analyses, which do not provide comprehensive efficacy data.
Safety Profile
Reported complications include limited data on adverse events due to the nature of the available studies. The evidence does not provide detailed safety outcomes specific to this device.
Evidence Limitations
The evidence base for the 9 French Large Lumen Triguide Plus Guiding Catheter is limited, with a lack of large-scale randomized controlled trials. Further research is needed to establish comprehensive efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for 9 French Large Lumen Triguide Plus Guiding Catheter?
The device is indicated for use in venous stenting procedures, particularly in interventional cardiology and radiology.
What outcomes have been reported in clinical studies?
Specific outcomes are not well-documented in the available studies, which primarily consist of case reports and retrospective analyses.
What complications have been reported?
Safety data from the evidence is limited, with no detailed reports of specific complications related to 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.