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braun percutaneous introducer set
B. Braun Medical
Summary: The Braun Percutaneous Introducer Set is a medical device used to facilitate vascular access for procedures like embolization. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K961745 ↗
Decision Date
September 17, 1996
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Braun Percutaneous Introducer Set was cleared through the FDA 510(k) pathway on September 17, 1996. It is manufactured by B. Braun Medical and classified as a Class 2 device under product code DYB.
What It Is
The Braun Percutaneous Introducer Set is designed to provide vascular access for the insertion of catheters or other medical devices into the vascular system. It typically includes a needle, guidewire, and sheath, allowing clinicians to perform procedures with minimal invasiveness. This set is crucial in procedures requiring precise vascular entry, such as embolization.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings for procedures like embolization, where precise vascular access is required. It is suitable for use in hospitals and specialized clinics, primarily for adult patients undergoing minimally invasive procedures. The introducer set is essential for ensuring safe and effective catheter placement.
Indications for Use
The FDA-cleared indications for this device involve facilitating vascular access for procedures like embolization. It is intended for patients who require minimally invasive interventions to treat vascular conditions.
Practical Considerations
The Braun Percutaneous Introducer Set is available in various sizes to accommodate different patient anatomies and procedural needs. Compatibility with other vascular devices is crucial, and proper technique is essential to minimize complications such as bleeding or vessel damage.
Frequently Asked Questions
What is the Braun Percutaneous Introducer Set used for?
It is used to provide vascular access for procedures like embolization, allowing for the insertion of catheters or other devices into the vascular system.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in hospital and specialized clinical settings.
What are the FDA-cleared indications?
The device is indicated for facilitating vascular access in procedures such as embolization, particularly for patients requiring minimally invasive interventions.
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.