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braun hemostasis introducers
B. Braun Medical
Summary: Braun Hemostasis Introducers are medical devices used to facilitate vascular access and hemostasis during interventional procedures. They are primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K955820 ↗
Decision Date
March 25, 1996
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Braun Hemostasis Introducers received FDA clearance through the 510(k) pathway on March 25, 1996. Manufactured by B. Braun Medical, this device is classified as Class 2 under product code DYB.
What It Is
The Braun Hemostasis Introducers are specialized medical devices designed to aid in the insertion of catheters into blood vessels while minimizing bleeding. They typically consist of a sheath and a dilator, allowing for smooth catheter introduction. These devices are crucial in maintaining hemostasis, especially during procedures that require repeated vascular access.
Clinical Applications
Commonly used in interventional radiology and cardiology, Braun Hemostasis Introducers are essential in procedures such as angiography, embolization, and catheter-based interventions. They are used in hospital settings, particularly in catheterization labs, and are suitable for adult and pediatric patients requiring vascular access.
Indications for Use
FDA indications for Braun Hemostasis Introducers include facilitating vascular access and maintaining hemostasis during interventional procedures. They are used in patients undergoing procedures that require catheter insertion into blood vessels.
Practical Considerations
These introducers come in various sizes to accommodate different catheter diameters and patient anatomies. Compatibility with other vascular access devices is crucial, and clinicians should be familiar with the insertion technique to ensure effective hemostasis and minimize complications.
Frequently Asked Questions
What is Braun Hemostasis Introducers used for?
They are used to facilitate vascular access and maintain hemostasis during interventional procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for facilitating vascular access and maintaining hemostasis during procedures requiring catheter insertion.
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.