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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 procedures. They are typically used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K960406 ↗
Decision Date
April 12, 1996
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Braun Hemostasis Introducers were cleared through the FDA 510(k) pathway on April 12, 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 designed to assist in gaining and maintaining vascular access while minimizing blood loss. They consist of a sheath and dilator system that allows for the insertion of catheters or other devices into the vascular system. The introducers help in achieving hemostasis, which is crucial in reducing complications during and after procedures.
Clinical Applications
These introducers are commonly used in interventional radiology and cardiology for procedures such as embolization, angiography, and catheter-based interventions. They are essential in settings where precise vascular access is required, such as in hospitals and specialized outpatient centers. The devices are suitable for adult and pediatric patients requiring vascular interventions.
Indications for Use
FDA indications suggest these devices are used for procedures involving embolization coils, which are often employed to treat aneurysms or other vascular abnormalities. They are intended for patients needing controlled vascular access and hemostasis.
Practical Considerations
Braun Hemostasis Introducers come in various sizes to accommodate different patient anatomies and procedural needs. They are compatible with a range of catheters and guidewires. Proper technique in insertion and removal is crucial to minimize vascular trauma and ensure effective hemostasis.
Frequently Asked Questions
What is Braun Hemostasis Introducers used for?
They are used to facilitate vascular access and hemostasis during interventional procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
They are indicated for use in procedures involving embolization coils and controlled vascular access.
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.