📊 Evidence-Based Reference
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 ?
510(k)
Number ?
K934988 ↗
Decision Date ?
January 14, 1994
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Percutaneous catheter use within the vascular system.
- Use as a guiding catheter to facilitate access and delivery of compatible therapeutic devices.
- Use in accordance with the manufacturer's labeling and instructions for use.
Clinical Applications
- Guiding compatible devices during percutaneous venous interventions.
- Providing access and support during procedures involving treatment of the iliac or central veins.
- Facilitating delivery of a compatible venous stent or other therapeutic device to the intended treatment site.
Reported off-label uses
- Use as a large-lumen access or support catheter during selected venous thrombectomy procedures may occur in clinical practice, but the specific indication should be confirmed against the current manufacturer's labeling.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- The catheter is identified as 9 French; confirm the outer diameter, working length, tip configuration, and usable inner diameter before selecting guidewires or other devices.
- Check compatibility with the intended guidewire, stent delivery system, thrombectomy device, introducer sheath, and access site.
- Use fluoroscopic or other appropriate imaging guidance and follow standard sterile catheterization technique.
- The available FDA record does not establish MRI safety; consult the current labeling before MRI or procedures involving the MR environment.
- Contraindications, warnings, storage limits, and maximum pressure or flow specifications should be taken from the current manufacturer's instructions for use.
Procedures that use this device
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.