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Concentric Medical
Summary: The Concentroc HD Guide Catheter, manufactured by Concentric Medical, is used in venous stent procedures. Key evidence includes studies on endovascular models and imaging modalities.
FDA Clearance Information
Pathway
510K
Number
K003880 ↗
Decision Date
May 16, 2001
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Concentroc HD Guide Catheter received FDA clearance via the 510(k) pathway on May 16, 2001. It is manufactured by Concentric Medical and classified as a Class 2 device.
What It Is
The Concentroc HD Guide Catheter is a medical device designed for use in venous stent procedures. It facilitates the delivery of stents to targeted vascular sites, aiding in the treatment of vascular conditions.
Clinical Applications
Commonly used in endovascular procedures, the Concentroc HD Guide Catheter assists in the placement of venous stents. It is particularly useful in scenarios requiring precise catheter navigation and stent deployment.
Evidence Summary
The available literature includes 10 studies, ranging from randomized controlled trials to systematic reviews, published between 2023 and 2025. These studies explore various aspects of endovascular procedures and imaging techniques.
Reported Outcomes
Published studies report advancements in catheter-based procedures, including improved stent placement accuracy and reduced procedural invasiveness. Studies highlight the catheter's role in facilitating complex endovascular interventions.
Safety Profile
Reported complications include procedural challenges such as catheter navigation difficulties and potential vascular injury. However, the studies emphasize the device's overall safety profile in clinical settings.
Evidence Limitations
The evidence is limited by the small sample sizes and the need for further research on long-term outcomes. Additional studies are required to fully understand the device's efficacy across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Concentroc HD Guide Catheter?
The device is indicated for use in venous stent procedures, aiding in the delivery and placement of stents within the vascular system.
What outcomes have been reported in clinical studies?
Studies have reported improved accuracy in stent placement and reduced invasiveness of procedures using the catheter.
What complications have been reported?
Safety data indicate potential complications such as catheter navigation difficulties and vascular injury, though overall safety is affirmed.
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.