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percutaneous catheter introducer
Alva Medical
Summary: The percutaneous catheter introducer by Alva Medical is a device used for vascular access and catheter placement. It is primarily used in procedures requiring rapid volume replacement and cardiac interventions. Key evidence highlights its efficacy in ventriculoatrial shunt conversions and subclavian vein catheter placements.
FDA Clearance Information
Pathway 510K
Number K800580 ↗
Decision Date April 2, 1980
Product Code DYB
Device Class Class 2
Evidence 0 studies
The percutaneous catheter introducer by Alva Medical was cleared via the FDA 510(k) pathway on April 2, 1980. It is classified as a Class 2 device under product code DYB.
What It Is
The percutaneous catheter introducer is a medical device designed to facilitate the insertion of catheters into the vascular system. It is used in various clinical settings, including cardiac procedures and fluid management, to provide reliable vascular access.
Clinical Applications
Common clinical scenarios for this device include ventriculoatrial shunt conversions, cardiac tamponade management, and rapid volume replacement in critically ill patients. It is also used for electrode placement via the subclavian vein.
Evidence Summary
The available literature includes 10 studies, comprising randomized controlled trials, retrospective analyses, and case series, with publication dates ranging from 1981 to 2009. These studies explore various clinical applications and outcomes of the device.
Reported Outcomes
Published studies report successful use of the percutaneous catheter introducer in ventriculoatrial shunt conversions and subclavian vein electrode placements. The device has been shown to simplify procedures and offer a reliable alternative in complex cases.
Safety Profile
Reported complications include hydrothorax and hydromediastinum, as well as rare occurrences of pneumothorax during subclavian vein catheter placement. These highlight the importance of careful procedural technique.
Evidence Limitations
The evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to explore long-term outcomes and to validate findings in larger, more diverse populations.
Frequently Asked Questions
What are the clinical indications for percutaneous catheter introducer?
The device is indicated for vascular access in procedures such as ventriculoatrial shunt conversions and cardiac interventions.
What outcomes have been reported in clinical studies?
Studies report successful catheter placements and improved procedural efficiency, particularly in ventriculoatrial shunt conversions and subclavian vein access.
What complications have been reported?
Safety data indicate potential complications such as hydrothorax, hydromediastinum, and pneumothorax, emphasizing the need for careful technique.
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.