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introducer assembly with rotator lock
Teleflex Medical
Summary: The introducer assembly with rotator lock by Teleflex Medical is a device used primarily in interventional radiology and cardiology for the placement of embolization coils. It is utilized by healthcare professionals to facilitate vascular access and device delivery.
FDA Clearance Information
Pathway
510K
Number
K060519 ↗
Decision Date
May 5, 2006
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on May 5, 2006. Manufactured by Teleflex Medical, it is classified as a Class II device under product code DYB.
What It Is
The introducer assembly with rotator lock is a medical device designed to assist in the precise placement of embolization coils within the vascular system. It features a rotator lock mechanism that allows for controlled manipulation and secure positioning of the device during procedures. This device is particularly useful in procedures requiring high precision and stability.
Clinical Applications
Commonly used in interventional radiology and cardiology, this device is essential for procedures involving embolization, where coils are deployed to occlude blood vessels. It is used in settings such as hospitals and specialized clinics, often for patients requiring treatment for aneurysms or vascular malformations. The device is suitable for adult and pediatric populations, depending on the clinical scenario.
Indications for Use
The FDA-cleared indications for this device include its use in the placement of embolization coils, which are used to treat conditions like aneurysms or to stop bleeding by occluding blood vessels. It is intended for patients needing precise vascular interventions.
Practical Considerations
Clinicians should be aware of the typical sizes available for this device to ensure compatibility with the patient's vascular anatomy. Proper technique in handling the rotator lock is crucial for optimal performance. It is compatible with a range of embolization coils and other interventional devices.
Frequently Asked Questions
What is the introducer assembly with rotator lock used for?
It is used for the precise placement of embolization coils in vascular procedures.
What specialties typically use this device?
Interventional radiology and cardiology specialists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for the placement of embolization coils to treat vascular conditions such as aneurysms.
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.