📋 FDA Reference
Braun Hemostasis Introducers
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 ?
510(k)
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.
FDA-Cleared Indications
- Facilitate percutaneous access to blood vessels for the introduction of catheters and other interventional devices.
- Provide a conduit for catheter-based vascular procedures.
- Help maintain hemostasis at the vascular access site during catheter insertion and removal.
Clinical Applications
- Vascular access for angiography and diagnostic catheter procedures.
- Access for catheter-based embolization procedures.
- Access for interventional radiology and cardiology procedures requiring placement of a vascular catheter.
- Use when a sheath is needed to support catheter exchange or repeated device passage during a procedure.
Practical Considerations
- Available sizes and configurations must match the intended catheter or device diameter and the access vessel.
- The operator should confirm compatibility among the sheath, dilator, guidewire, catheter and other procedural equipment before use.
- Insertion is generally performed percutaneously over a guidewire using sterile technique and imaging guidance when appropriate.
- The sheath and dilator are single-use vascular access components; they are not intended to remain permanently implanted.
- MRI safety depends on the specific model and materials. The product labeling should be checked before MRI, particularly if any component remains in the patient.
Procedures that use this device
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.