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scimed 8 french triguide guiding catheter
Scimed Life Systems
Summary: The Scimed 8 French Triguide Guiding Catheter is used in venous stent procedures. It is FDA-cleared and supported by studies focusing on its use in coronary angioplasty and stent deployment.
FDA Clearance Information
Pathway
510K
Number
K940603 ↗
Decision Date
April 19, 1994
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Scimed 8 French Triguide Guiding Catheter was cleared by the FDA via the 510(k) pathway on April 19, 1994. It is manufactured by Scimed Life Systems and classified as a Class 2 device.
What It Is
The Scimed 8 French Triguide Guiding Catheter is a medical device designed for use in guiding stents and other instruments during venous procedures. It is intended for use in coronary and peripheral vascular interventions.
Clinical Applications
This catheter is commonly used in procedures such as percutaneous transluminal coronary angioplasty (PTCA) and stent implantation. It is particularly useful in scenarios requiring precise guidance of interventional tools.
Evidence Summary
The available literature includes four studies ranging from 1991 to 2002, encompassing case series and other study types. These studies focus on the catheter's application in coronary interventions.
Reported Outcomes
Published studies report successful use of the Scimed 8 French Triguide Guiding Catheter in coronary angioplasty and stent implantation. Outcomes include effective stent deployment and improved coronary visualization.
Safety Profile
Reported complications include potential issues related to catheter size and maneuverability. However, specific adverse events are not detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and lack of large-scale randomized controlled trials. Further research is needed to fully understand the long-term safety and efficacy of this device.
Frequently Asked Questions
What are the clinical indications for Scimed 8 French Triguide Guiding Catheter?
The device is indicated for use in venous stent procedures, particularly in coronary angioplasty and stent implantation.
What outcomes have been reported in clinical studies?
Studies report successful stent deployment and improved visualization during coronary interventions.
What complications have been reported?
Safety data suggest potential complications related to catheter size and maneuverability, though specific adverse events are not detailed.
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.