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scimed 7 french wiseguide guide catheter
Scimed Life Systems
Summary: The Scimed 7 French Wiseguide Guide Catheter is a device used primarily for venous stenting procedures. Key evidence highlights its use in minimally invasive approaches for stenting, with studies exploring its feasibility and outcomes.
FDA Clearance Information
Pathway
510K
Number
K974684 ↗
Decision Date
February 19, 1998
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Scimed 7 French Wiseguide Guide Catheter was cleared by the FDA through the 510(k) pathway on February 19, 1998. It is manufactured by Scimed Life Systems and classified as a Class 2 device.
What It Is
The Scimed 7 French Wiseguide Guide Catheter is designed for use in venous stenting procedures. It facilitates the delivery of stents to target sites within the vasculature, providing support and guidance during minimally invasive interventions.
Clinical Applications
This device is commonly used in procedures such as renal and coronary angioplasty, where precise catheter guidance is essential. It is particularly useful in transradial and femoral approaches for stenting.
Evidence Summary
The available literature includes six studies, ranging from 1993 to 2002, encompassing various study designs such as RCTs and case series. These studies explore the feasibility and outcomes of using the catheter in different clinical scenarios.
Reported Outcomes
Published studies report successful stent deployment in renal and coronary arteries using the Scimed catheter. The device has been associated with high procedural success rates in both transradial and femoral approaches, with effective stent placement and minimal complications.
Safety Profile
Reported complications include potential vascular access site issues and procedural challenges related to catheter navigation. However, the studies generally indicate a favorable safety profile with no major adverse events directly attributed to the device.
Evidence Limitations
The evidence is limited by small sample sizes and the lack of long-term follow-up data. Further research is needed to assess the long-term efficacy and safety of the device in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Scimed 7 French Wiseguide Guide Catheter?
The device is indicated for use in venous stenting procedures, including renal and coronary angioplasty.
What outcomes have been reported in clinical studies?
Studies report high procedural success rates with effective stent placement and minimal complications.
What complications have been reported?
Safety data indicate potential vascular access site issues and procedural challenges, but no major adverse events directly linked to the 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.