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pathway access sheath catheter
Vertelink
Summary: The pathway access sheath catheter by Vertelink is a medical device cleared by the FDA for use in embolization-coils procedures. Key evidence highlights its application in various clinical scenarios, though specific outcomes and safety data are limited.
FDA Clearance Information
Pathway
510K
Number
K030734 ↗
Decision Date
September 10, 2003
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The pathway access sheath catheter was cleared by the FDA through the 510(k) pathway on September 10, 2003. It is manufactured by Vertelink and classified as a Class 2 device under product code DYB.
What It Is
The pathway access sheath catheter is designed to facilitate the introduction of interventional devices into the vascular system. It is primarily used in procedures involving embolization coils, providing a conduit for device delivery.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures requiring vascular access, such as embolization of vascular abnormalities. It is particularly useful in scenarios where precise device placement is critical.
Evidence Summary
The available literature includes 11 studies, encompassing various study types such as case reports and experimental studies, with publication years ranging from 2022 to 2024. These studies explore different aspects of vascular access and interventional procedures.
Reported Outcomes
Published studies report varied outcomes related to the use of the pathway access sheath catheter, though specific efficacy data is not detailed in the provided evidence. The studies highlight its role in facilitating complex vascular procedures.
Safety Profile
Reported complications include potential risks associated with vascular access procedures, such as bleeding and vessel injury. However, specific safety data from the provided studies is limited.
Evidence Limitations
The evidence base for the pathway access sheath catheter is limited by a lack of large-scale randomized controlled trials. Further research is needed to better understand its efficacy and safety profile in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for the pathway access sheath catheter?
The device is indicated for use in procedures involving embolization coils, providing vascular access for interventional devices.
What outcomes have been reported in clinical studies?
Specific outcomes are not detailed in the provided evidence, but the device is noted for its role in facilitating complex vascular procedures.
What complications have been reported?
Reported complications include risks typical of vascular access procedures, such as bleeding and vessel injury, though specific data is limited.
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.