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5f guiding catheter
Guidant
Summary: The 5f guiding catheter by Guidant is used primarily for cardiac catheterization, particularly in trans-radial approaches. Key evidence highlights its reliability in coronary physiology assessment.
FDA Clearance Information
Pathway
510K
Number
K000598 ↗
Decision Date
March 24, 2000
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The 5f guiding catheter was cleared by the FDA via the 510(k) pathway on March 24, 2000. Manufactured by Guidant, it is classified as a Class 2 medical device.
What It Is
The 5f guiding catheter is a medical device designed for use in cardiac catheterization procedures. It facilitates the delivery of interventional devices and contrast media to coronary arteries, particularly through a trans-radial approach.
Clinical Applications
Commonly used in percutaneous coronary interventions (PCI), the 5f guiding catheter is employed in scenarios requiring coronary physiology assessment and complex lesion management. It is particularly beneficial in procedures involving the right coronary artery.
Evidence Summary
The literature includes 15 studies, comprising randomized controlled trials, prospective and retrospective analyses, and case series, published between 2022 and 2024. These studies evaluate the device's reliability, safety, and clinical outcomes.
Reported Outcomes
Published studies report that the 5f guiding catheter is effective in coronary physiology assessment, with reliable and reproducible results. It has been successfully used in complex PCI, demonstrating feasibility and safety in these procedures.
Safety Profile
Reported complications include iatrogenic aortocoronary dissection during right coronary artery procedures. The risk factors and management strategies for such complications remain areas of ongoing research.
Evidence Limitations
Evidence gaps include limited characterization of risk factors for complications and a need for more comprehensive management strategies. Further research is required to optimize the use of the 5f guiding catheter in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for 5f guiding catheter?
The 5f guiding catheter is indicated for use in cardiac catheterization, particularly in trans-radial approaches for coronary physiology assessment and complex PCI.
What outcomes have been reported in clinical studies?
Clinical studies have reported reliable and reproducible results in coronary physiology assessment and successful use in complex PCI.
What complications have been reported?
Safety data indicate complications such as iatrogenic aortocoronary dissection during right coronary artery procedures.
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.