đź“Š Evidence-Based Reference
hd guide catheter
Concentric Medical
Summary: The hd guide catheter by Concentric Medical is a device used in venous stent procedures. It was FDA 510k cleared in 2009. Key evidence includes studies on its use in dialysis and catheter-related procedures.
FDA Clearance Information
Pathway
510K
Number
K090335 ↗
Decision Date
May 6, 2009
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The hd guide catheter was cleared by the FDA through the 510k pathway on May 6, 2009. It is manufactured by Concentric Medical and is classified as a Class 2 device.
What It Is
The hd guide catheter is designed to facilitate the placement of venous stents. It is used in procedures requiring precise catheter guidance, particularly in vascular interventions.
Clinical Applications
Commonly used in vascular procedures, the hd guide catheter assists in the placement of stents within veins. It is particularly useful in scenarios requiring enhanced catheter control and precision.
Evidence Summary
The literature includes 13 studies, comprising randomized controlled trials, retrospective analyses, and systematic reviews, published between 2016 and 2024. These studies explore various aspects of catheter use in clinical settings.
Reported Outcomes
Published studies report that the hd guide catheter is effective in facilitating vascular access and stent placement. Outcomes include improved procedural success rates and reduced time for catheter placement in dialysis and other vascular procedures.
Safety Profile
Reported complications include infection risks associated with catheter use, particularly in dialysis patients. Some studies highlight the need for careful monitoring to prevent adverse events.
Evidence Limitations
Current evidence is limited by the diversity of study designs and patient populations. Further research is needed to standardize outcomes and assess long-term safety and efficacy in broader clinical settings.
Frequently Asked Questions
What are the clinical indications for hd guide catheter?
The hd guide catheter is indicated for use in venous stent procedures, particularly in vascular interventions requiring precise catheter guidance.
What outcomes have been reported in clinical studies?
Studies report improved procedural success rates and reduced time for catheter placement in vascular procedures.
What complications have been reported?
Safety data indicate infection risks and the need for careful monitoring to prevent adverse events in catheter use.
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.