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introducer sheaths vessel dilator guidewire
Boston Scientific
Summary: The introducer sheaths vessel dilator guidewire by Boston Scientific is used for vascular access. It is FDA 510k cleared and linked to studies on embolization and airway access.
FDA Clearance Information
Pathway
510K
Number
K994252 ↗
Decision Date
January 4, 2000
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510k pathway on January 4, 2000. Manufactured by Boston Scientific, it is classified as a Class 2 medical device.
What It Is
The introducer sheaths vessel dilator guidewire is designed to facilitate vascular access by dilating vessels and guiding catheters. It is used in procedures requiring precise entry into blood vessels.
Clinical Applications
Commonly used in endovascular procedures, this device aids in the introduction of catheters or other instruments into the vascular system. It is essential in scenarios like embolization or tracheostomy.
Evidence Summary
The literature includes two studies: one from 1997 and another from 2006. These studies explore applications in embolization and airway access, providing insights into procedural techniques.
Reported Outcomes
Published studies report the device's effectiveness in facilitating embolization procedures and airway access in animal models. The studies highlight its utility in preventing type II endoleak and providing airway access.
Safety Profile
Reported complications include potential procedural risks associated with vascular access and airway management. However, specific adverse events are not detailed in the provided studies.
Evidence Limitations
The evidence is limited to two studies with specific procedural contexts. Further research is needed to explore broader clinical applications and long-term safety outcomes.
Frequently Asked Questions
What are the clinical indications for introducer sheaths vessel dilator guidewire?
The device is indicated for use in vascular access procedures, such as embolization and airway management.
What outcomes have been reported in clinical studies?
Studies report successful prevention of type II endoleak and effective airway access in animal models.
What complications have been reported?
Reported complications include general procedural risks, but specific adverse events are not detailed in the studies.
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.