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airguard valved introducer
C.R. Bard
Summary: The Airguard Valved Introducer by C.R. Bard is a device used in embolization procedures. It was FDA-cleared via the 510k pathway in 2004. Key evidence highlights its application in interventional cardiology and related fields.
FDA Clearance Information
Pathway
510K
Number
K042036 ↗
Decision Date
August 23, 2004
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Airguard Valved Introducer was cleared by the FDA through the 510k pathway on August 23, 2004. Manufactured by C.R. Bard, it is classified as a Class 2 device under product code DYB.
What It Is
The Airguard Valved Introducer is a medical device designed for use in embolization procedures, particularly involving coils. It facilitates the introduction of catheters and other instruments into the vascular system while minimizing blood loss.
Clinical Applications
Commonly used in interventional cardiology, the Airguard Valved Introducer is employed in procedures requiring vascular access, such as embolization and other catheter-based interventions. It is particularly useful in scenarios where maintaining hemostasis is critical.
Evidence Summary
The literature includes 10 studies ranging from 2009 to 2025, encompassing various study types such as RCTs, prospective, and retrospective analyses. These studies explore the device's application in different clinical settings.
Reported Outcomes
Published studies report the Airguard Valved Introducer as effective in facilitating vascular access with minimal complications. Its use in embolization procedures has been associated with successful outcomes in maintaining hemostasis and reducing procedural time.
Safety Profile
Reported complications include vascular complications such as thrombosis and limb ischemia, particularly in large bore access procedures. However, these are generally manageable with appropriate clinical intervention.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale randomized controlled trials. Further research is needed to establish long-term safety and efficacy across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Airguard Valved Introducer?
The device is indicated for use in embolization procedures, particularly involving coils, and in scenarios requiring vascular access.
What outcomes have been reported in clinical studies?
Studies report effective facilitation of vascular access with minimal complications, particularly in embolization procedures.
What complications have been reported?
Safety data indicate potential complications such as thrombosis and limb ischemia, especially in large bore access 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.