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usci r hemaflex tm introducer with coating
C.R. Bard
Summary: The USCI R HemaFlex Introducer with coating is a medical device used primarily in interventional radiology and cardiology for vascular access. It is designed for clinicians performing procedures that require the introduction of embolization coils.
FDA Clearance Information
Pathway
510K
Number
K915553 ↗
Decision Date
February 21, 1992
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The USCI R HemaFlex Introducer was cleared through the FDA 510(k) pathway on February 21, 1992. Manufactured by C.R. Bard, it is classified as a Class II device under product code DYB.
What It Is
The USCI R HemaFlex Introducer is a vascular access device that facilitates the insertion of embolization coils and other interventional tools into the vascular system. It features a specialized coating to reduce friction and improve ease of insertion. This device is typically used in procedures that require precise and reliable vascular access, such as embolization therapies.
Clinical Applications
This introducer is commonly used in interventional radiology and cardiology settings, particularly for procedures involving embolization coils. It is suitable for use in hospitals and specialized clinics where vascular interventions are performed. The device is often employed in treating conditions like aneurysms or vascular malformations, where precise delivery of embolization materials is critical.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures requiring the insertion of embolization coils. It is typically used in patients needing vascular interventions to treat or manage conditions such as aneurysms or arteriovenous malformations.
Practical Considerations
The USCI R HemaFlex Introducer comes in various sizes to accommodate different vascular access needs. It is compatible with standard embolization coils and other interventional devices. Clinicians should be trained in vascular access techniques to ensure proper use and minimize complications.
Frequently Asked Questions
What is USCI R HemaFlex Introducer used for?
It is used for vascular access in procedures requiring the insertion of embolization coils, such as in the treatment of aneurysms.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in hospital and specialized clinical settings.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring the introduction of embolization coils, typically for vascular 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.