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usci hemaquet xt introducer
C.R. Bard
Summary: The usci hemaquet xt introducer is a medical device used to facilitate the insertion of embolization coils in vascular procedures. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K920251 ↗
Decision Date
March 18, 1992
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The usci hemaquet xt introducer was cleared through the FDA 510k pathway on March 18, 1992. Manufactured by C.R. Bard, it is classified as a Class 2 device under product code DYB.
What It Is
The usci hemaquet xt introducer is a specialized catheter designed to aid in the placement of embolization coils within blood vessels. It provides a conduit for the safe and precise delivery of these coils, which are used to occlude blood flow in targeted areas. The device is integral in minimally invasive procedures, allowing clinicians to navigate complex vascular anatomy with greater ease.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings, particularly for procedures involving the embolization of aneurysms or arteriovenous malformations. It is suitable for use in both inpatient and outpatient settings, catering to adult and pediatric populations requiring vascular interventions. The introducer is essential in procedures where precise coil placement is critical to patient outcomes.
Indications for Use
The FDA indications for the usci hemaquet xt introducer involve its use in procedures requiring the placement of embolization coils. It is intended for patients needing vascular occlusion to treat conditions like aneurysms or vascular malformations.
Practical Considerations
Clinicians should consider the appropriate sizing of the introducer to match the patient's vascular anatomy and the specific embolization coils being used. Compatibility with other interventional tools and the technique for insertion should be reviewed to ensure optimal outcomes.
Frequently Asked Questions
What is usci hemaquet xt introducer used for?
It is used for facilitating the insertion of embolization coils in vascular procedures to occlude blood flow in targeted areas.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring the placement of embolization coils, such as treating aneurysms or vascular malformations.
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.