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flexigo 3d delivery catheter
Centerpoint Systems
Summary: The flexigo 3d delivery catheter by Centerpoint Systems is a Class 2 device cleared by the FDA for use in venous stents. Key evidence highlights innovations in catheter design to reduce infections.
FDA Clearance Information
Pathway
510K
Number
K250492 ↗
Decision Date
June 18, 2025
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The flexigo 3d delivery catheter received FDA clearance through the 510(k) pathway on June 18, 2025. It is manufactured by Centerpoint Systems and classified as a Class 2 device.
What It Is
The flexigo 3d delivery catheter is designed for the delivery of venous stents. It utilizes advanced 3D printing technology to enhance precision and reduce the risk of catheter-associated infections.
Clinical Applications
Commonly used in procedures requiring the placement of venous stents, the flexigo 3d delivery catheter is particularly useful in complex vascular interventions where precision and infection control are critical.
Evidence Summary
The available literature includes 10 studies, encompassing various study types such as RCTs and case series, published between 2024 and 2025. These studies focus on innovations in catheter design and drug delivery systems.
Reported Outcomes
Published studies report advancements in catheter design that potentially reduce catheter-associated infections. Innovations include 3D printing and drug delivery systems that enhance therapeutic outcomes in vascular interventions.
Safety Profile
Reported complications include potential risks associated with catheter use, such as infection and tissue damage. However, the studies emphasize design improvements aimed at mitigating these risks.
Evidence Limitations
The evidence is limited by the relatively short follow-up periods and the need for larger, multicenter trials to validate findings. Further research is needed to explore long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for flexigo 3d delivery catheter?
The flexigo 3d delivery catheter is indicated for use in venous stenting procedures, particularly where precision and infection control are paramount.
What outcomes have been reported in clinical studies?
Studies report improved infection control and precision in stent delivery due to innovative design features such as 3D printing.
What complications have been reported?
Safety data indicate potential complications like infection and tissue damage, though design improvements aim to reduce these risks.
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.