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modified teleflex medical introducer catheter
Teleflex
Summary: The modified Teleflex Medical Introducer Catheter is a Class 2 medical device used primarily for vascular access and the introduction of embolization coils. It is commonly utilized by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K861951 ↗
Decision Date
June 19, 1986
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA's 510(k) pathway on June 19, 1986. It is manufactured by Teleflex and classified as a Class 2 device under product code DYB.
What It Is
The modified Teleflex Medical Introducer Catheter is a specialized catheter designed to facilitate the introduction of other devices, such as embolization coils, into the vascular system. It provides a stable and secure pathway for these devices, ensuring precise placement within the vasculature. The catheter's design typically includes features that minimize trauma to the vessel walls during insertion.
Clinical Applications
This device is commonly used in interventional radiology and cardiology procedures, particularly for embolization therapies where precise delivery of coils is necessary to occlude blood vessels. It is often employed in settings such as hospitals and specialized outpatient centers, catering to patients requiring vascular interventions, such as those with aneurysms or arteriovenous malformations.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures requiring vascular access for the delivery of embolization coils. It is suitable for patients needing targeted vascular occlusion, often due to conditions like aneurysms or abnormal blood vessel formations.
Practical Considerations
Clinicians should consider the appropriate size of the introducer catheter based on the patient's vessel size and the specific procedure. Compatibility with other devices, such as embolization coils, is crucial for successful outcomes. Proper technique in insertion and handling is essential to minimize complications such as vessel trauma or dislodgement.
Frequently Asked Questions
What is the modified Teleflex Medical Introducer Catheter used for?
It is used for vascular access and the introduction of embolization coils into the vascular system.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring vascular access for the delivery of embolization coils, particularly in patients with 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.