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baxter hemostasis valve introducers
Baxter Edwards
Summary: The Baxter Hemostasis Valve Introducers are medical devices used to facilitate the insertion of catheters and other devices into the vascular system, primarily by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K981909 ↗
Decision Date
November 24, 1998
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Baxter Hemostasis Valve Introducers were cleared through the FDA 510k pathway on November 24, 1998. Manufactured by Baxter Edwards, this device is classified as a Class 2 medical device.
What It Is
The Baxter Hemostasis Valve Introducers are designed to provide a secure and hemostatic entry point into the vascular system. They work by allowing the passage of catheters and other interventional tools while minimizing blood loss. The device features a valve mechanism that maintains hemostasis during procedures, which is crucial in reducing the risk of complications such as bleeding.
Clinical Applications
These introducers are commonly used in interventional cardiology and radiology procedures, such as angiography, embolization, and the placement of stents or coils. They are essential in settings like hospitals and specialized clinics where minimally invasive vascular interventions are performed. The device is particularly useful for patients requiring precise vascular access and management.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures requiring vascular access, particularly where embolization coils are involved. It is suitable for patients undergoing interventional procedures that necessitate the introduction of devices into the vascular system.
Practical Considerations
Clinicians should consider the compatibility of the introducer with the catheters and devices being used. Typical sizing may vary, so it is important to select the appropriate size for the patient's anatomy and the specific procedure. Proper technique in valve operation is essential to maintain hemostasis and prevent complications.
Frequently Asked Questions
What is Baxter Hemostasis Valve Introducers used for?
It is used to facilitate the insertion of catheters and other devices into the vascular system while maintaining hemostasis.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in procedures requiring vascular access.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring vascular access, particularly those 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.