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fluoro-tip r hemostasis valve introducer set
B. Braun Medical
Summary: The Fluoro-tip R Hemostasis Valve Introducer Set is a medical device used to facilitate the insertion of catheters and other devices into the vascular system. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K945396 ↗
Decision Date
March 13, 1995
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Fluoro-tip R Hemostasis Valve Introducer Set was cleared by the FDA via the 510(k) pathway on March 13, 1995. It is manufactured by B. Braun Medical and is classified as a Class 2 device under product code DYB.
What It Is
The Fluoro-tip R Hemostasis Valve Introducer Set is designed to provide vascular access while minimizing blood loss during catheterization procedures. It includes a hemostasis valve that helps maintain a seal around the catheter, reducing the risk of air embolism and blood leakage. This device is particularly useful in procedures requiring repeated catheter exchanges.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures such as angiography, embolization, and the placement of embolization coils. It is suitable for use in hospital settings, particularly in catheterization labs, and is used for both diagnostic and therapeutic interventions. The device is often utilized in adult patients requiring vascular access for complex procedures.
Indications for Use
The FDA indications for this device include facilitating the insertion and exchange of catheters in the vascular system. It is intended for patients undergoing procedures that require vascular access, such as those involving embolization coils.
Practical Considerations
The introducer set typically comes in various sizes to accommodate different catheter dimensions, ensuring compatibility with a range of interventional devices. Clinicians should be familiar with the technique for inserting the introducer to minimize complications such as vessel trauma or air embolism.
Frequently Asked Questions
What is the Fluoro-tip R Hemostasis Valve Introducer Set used for?
It is used to facilitate the insertion and exchange of catheters in the vascular system, particularly during interventional procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in catheterization labs during vascular procedures.
What are the FDA-cleared indications?
The device is indicated for facilitating the insertion and exchange of catheters in the vascular system, especially in procedures involving embolization coils.
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.