đź“‹ FDA Reference
intro-flex sheath introducer w amc thromboshield
Baxter Healthcare
Summary: The Intro-Flex Sheath Introducer w AMC Thromboshield is a medical device used primarily in vascular procedures to facilitate the introduction of catheters and other devices into the vasculature. It is commonly used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K885179 ↗
Decision Date
August 9, 1989
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Intro-Flex Sheath Introducer w AMC Thromboshield was cleared through the FDA 510(k) pathway on August 9, 1989. Manufactured by Baxter Healthcare, it is classified as a Class 2 device under product code DYB.
What It Is
The Intro-Flex Sheath Introducer with AMC Thromboshield is a specialized medical device designed to provide a conduit for the insertion of catheters and other instruments into the vascular system. It features a sheath that minimizes trauma to the vessel and a hemostatic valve to prevent blood loss during procedures. The AMC Thromboshield technology is intended to reduce the risk of thrombosis at the insertion site.
Clinical Applications
This device is commonly used in interventional procedures such as angiography, angioplasty, and embolization. It is particularly useful in settings where vascular access is required, such as in cardiac catheterization labs or interventional radiology suites. The device is suitable for a wide range of patient populations, including those undergoing diagnostic or therapeutic vascular interventions.
Indications for Use
The Intro-Flex Sheath Introducer is indicated for use in procedures requiring vascular access, such as the introduction of catheters for diagnostic or therapeutic purposes. It is suitable for patients needing interventions like embolization or angioplasty.
Practical Considerations
The device is available in various sizes to accommodate different vessel diameters and procedural requirements. It is compatible with a range of catheters and guidewires. Clinicians should be familiar with the insertion technique to minimize complications such as vessel trauma or thrombosis.
Frequently Asked Questions
What is the Intro-Flex Sheath Introducer w AMC Thromboshield used for?
It is used to facilitate the introduction of catheters and other devices into the vascular system during interventional procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in vascular procedures.
What are the FDA-cleared indications?
It is indicated for use in procedures requiring vascular access, such as catheter introduction for diagnostic or therapeutic interventions.
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.