đź“‹ FDA Reference
usci r hemaquet tm introducer w obturator
C.R. Bard
Summary: The usci r hemaquet tm introducer with obturator is a medical device used for vascular access, particularly in procedures involving embolization coils. It is commonly used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K884104 ↗
Decision Date
December 21, 1988
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on December 21, 1988. Manufactured by C.R. Bard, it is classified as a Class II device under product code DYB.
What It Is
The usci r hemaquet tm introducer with obturator is a medical device designed to facilitate the insertion of embolization coils into the vascular system. It consists of an introducer sheath and an obturator, which help guide the coils to the target site within blood vessels. This device is crucial in procedures requiring precise vascular access and coil deployment.
Clinical Applications
This device is primarily used in interventional radiology and vascular surgery for embolization procedures. It is commonly employed in the treatment of vascular abnormalities such as aneurysms or arteriovenous malformations. The device is suitable for use in both hospital and outpatient settings, and it is typically used in adult patients requiring endovascular intervention.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures requiring the introduction of embolization coils into the vascular system. It is used in patients with conditions that necessitate the occlusion of blood vessels to prevent or control bleeding.
Practical Considerations
The device is available in various sizes to accommodate different vessel diameters and patient anatomies. It is compatible with standard embolization coils and requires careful handling to ensure proper placement. Clinicians should be trained in vascular access techniques to use this device effectively.
Frequently Asked Questions
What is usci r hemaquet tm introducer w obturator used for?
It is used for vascular access in procedures involving the insertion of embolization coils, particularly in interventional radiology and vascular surgery.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring the introduction of embolization coils into the vascular system to occlude blood vessels.
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.