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cook coronary guiding catheter
Cook
Summary: The Cook Coronary Guiding Catheter is a device used in coronary interventions to guide other instruments to the target site. Key evidence highlights its role in venous stent procedures.
FDA Clearance Information
Pathway
510K
Number
K902905 ↗
Decision Date
September 4, 1990
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Cook Coronary Guiding Catheter was cleared through the FDA 510(k) pathway on September 4, 1990. It is manufactured by Cook and classified as a Class 2 device.
What It Is
The Cook Coronary Guiding Catheter is designed to facilitate the delivery of interventional devices to coronary arteries. It is used in procedures requiring precise navigation and support for other instruments.
Clinical Applications
This catheter is commonly used in coronary angioplasty and stenting procedures. It provides support and guidance for devices used in treating coronary artery disease.
Evidence Summary
The literature includes 10 studies, comprising various study types such as RCTs and prospective analyses, published between 2024 and 2025. These studies explore the catheter's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report that the Cook Coronary Guiding Catheter is effective in facilitating coronary interventions, particularly in venous stent placements. Outcomes indicate improved procedural success rates and device navigation.
Safety Profile
Reported complications include potential for vascular injury and thrombosis, as noted in the literature. However, these events are relatively infrequent and manageable with proper technique.
Evidence Limitations
The evidence is limited by the small sample sizes and short follow-up durations in some studies. Further research is needed to assess long-term outcomes and comparative effectiveness against other guiding catheters.
Frequently Asked Questions
What are the clinical indications for Cook Coronary Guiding Catheter?
The catheter is indicated for use in coronary interventions, particularly in procedures involving venous stents.
What outcomes have been reported in clinical studies?
Studies report improved procedural success and effective navigation in coronary interventions using the catheter.
What complications have been reported?
Safety data indicate potential complications such as vascular injury and thrombosis, though these are infrequent.
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.