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angestat fluoro-tip hemostasis introducer set
B. Braun Medical
Summary: The Angestat Fluoro-Tip Hemostasis Introducer Set by B. Braun Medical is a device used for vascular access and hemostasis. It is FDA 510k cleared and linked to studies focusing on vascular closure devices and procedural innovations.
FDA Clearance Information
Pathway
510K
Number
K930057 ↗
Decision Date
August 6, 1993
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Angestat Fluoro-Tip Hemostasis Introducer Set was cleared through the FDA 510k pathway on August 6, 1993. It is manufactured by B. Braun Medical and classified as a Class 2 device.
What It Is
The Angestat Fluoro-Tip Hemostasis Introducer Set is designed for vascular access and hemostasis during interventional procedures. It facilitates the introduction of catheters and other devices into the vasculature.
Clinical Applications
Commonly used in procedures requiring vascular access, such as embolization and other interventional radiology applications. It is particularly useful in scenarios where precise hemostasis is critical.
Evidence Summary
The available literature includes three studies ranging from 2011 to 2018. These studies encompass various methodologies, including retrospective and prospective analyses, focusing on vascular closure and procedural techniques.
Reported Outcomes
Published studies report the successful implementation of vascular closure devices in achieving hemostasis during interventional procedures. The studies highlight the feasibility and safety of these devices in clinical practice.
Safety Profile
Reported complications include procedural interruptions and the need for alternative techniques in certain cases. However, the studies generally support the safety profile of the device in achieving hemostasis.
Evidence Limitations
The evidence is limited by the small number of studies and the variability in study design. Further research is needed to establish long-term outcomes and to compare the device with alternative hemostasis methods.
Frequently Asked Questions
What are the clinical indications for Angestat Fluoro-Tip Hemostasis Introducer Set?
The device is indicated for vascular access and hemostasis in interventional procedures, particularly in embolization and similar applications.
What outcomes have been reported in clinical studies?
Studies report successful hemostasis and feasibility of use in interventional procedures, with a focus on vascular closure.
What complications have been reported?
Reported complications include procedural interruptions and the need for alternative techniques, though overall safety is supported by 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.