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greco-harvey surfactant bonded catheter for cardio
Cook
Summary: The Greco-Harvey Surfactant Bonded Catheter by Cook is a Class 2 medical device cleared by the FDA for use in cardiovascular procedures. Key evidence highlights its potential in reducing biofouling and improving patient outcomes.
FDA Clearance Information
Pathway
510K
Number
K851241 ↗
Decision Date
February 26, 1986
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Greco-Harvey Surfactant Bonded Catheter was cleared through the FDA 510(k) pathway on February 26, 1986. It is manufactured by Cook and classified as a Class 2 device.
What It Is
The Greco-Harvey Surfactant Bonded Catheter is designed for cardiovascular applications, utilizing a surfactant-bonded surface to reduce biofouling and improve device performance. It is intended for use in procedures requiring catheterization.
Clinical Applications
Commonly used in cardiovascular procedures, the catheter is applied in scenarios where reducing infection risk and improving device longevity are critical. It is particularly relevant in ablation and venous stenting procedures.
Evidence Summary
The literature includes 10 studies, ranging from 2002 to 2021, with various study designs including RCTs and case series. These studies explore the catheter's efficacy in reducing biofouling and its mechanical properties.
Reported Outcomes
Published studies report that the surfactant-bonded surface of the catheter effectively reduces biofouling, potentially lowering infection rates. The device has shown promise in maintaining mechanical integrity and drug delivery capabilities.
Safety Profile
Reported complications include potential cytotoxicity and challenges in drug release efficiency, as noted in some studies. However, the overall safety profile is considered favorable with proper usage.
Evidence Limitations
Evidence gaps include a lack of large-scale, long-term studies to fully assess the catheter's efficacy and safety. Further research is needed to explore its performance in diverse clinical settings and patient populations.
Frequently Asked Questions
What are the clinical indications for the Greco-Harvey Surfactant Bonded Catheter?
The catheter is indicated for use in cardiovascular procedures, particularly in ablation and venous stenting, as per FDA documentation.
What outcomes have been reported in clinical studies?
Studies report reduced biofouling and improved mechanical properties, enhancing the catheter's efficacy in clinical settings.
What complications have been reported?
Safety data indicate potential cytotoxicity and drug release challenges, though these are generally manageable with proper device handling.
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.