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percutaneous introducers
Davol
Summary: Percutaneous introducers by Davol are used for vascular access in interventional procedures. They are FDA 510k cleared and linked to embolization-coils. Key evidence includes studies on pressure measurements and procedural outcomes.
FDA Clearance Information
Pathway
510K
Number
K903530 ↗
Decision Date
October 22, 1990
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The percutaneous introducers by Davol were cleared through the FDA 510k pathway on October 22, 1990. They are classified as Class 2 medical devices under product code DYB.
What It Is
Percutaneous introducers are medical devices used to facilitate vascular access during interventional procedures. They are designed to introduce catheters or other devices into the vascular system, primarily for diagnostic or therapeutic purposes.
Clinical Applications
Commonly used in procedures requiring vascular access, such as embolization, angiography, and other endovascular interventions. They provide a conduit for the insertion of various interventional tools.
Evidence Summary
The available literature includes 6 studies, with a mix of study types such as RCTs and case series. The studies span from 2003 to recent years, focusing on procedural outcomes and device performance.
Reported Outcomes
Published studies report on the efficacy of percutaneous introducers in facilitating vascular access and measuring intrapleural pressures. The devices have been used in studies involving horses to assess pressure fluctuations during exercise.
Safety Profile
Reported complications include potential pressure fluctuations during use, as noted in studies involving intrapleural pressure measurements. No specific adverse events were detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the lack of detailed outcomes and safety data in the provided studies. Further research is needed to explore long-term safety and efficacy in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for percutaneous introducers?
Percutaneous introducers are indicated for use in vascular access during interventional procedures, such as embolization and angiography.
What outcomes have been reported in clinical studies?
Studies have reported on the efficacy of these devices in facilitating vascular access and measuring intrapleural pressures.
What complications have been reported?
Reported complications include potential pressure fluctuations during use, with no specific adverse events detailed in the provided evidence.
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.