đź“‹ FDA Reference
teleflex medical introducer catheter
Teleflexmedical
Summary: The Teleflex Medical Introducer Catheter is a Class 2 medical device used primarily for vascular access during procedures such as embolization. It is utilized by interventional radiologists and other specialists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K851141 ↗
Decision Date
May 16, 1985
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Teleflex Medical Introducer Catheter was cleared via the FDA 510(k) pathway on May 16, 1985. Manufactured by Teleflexmedical, it is classified as a Class 2 device under product code DYB.
What It Is
The Teleflex Medical Introducer Catheter is a device designed to facilitate the introduction of other medical instruments into the vascular system. It typically consists of a flexible tube that can be inserted into a blood vessel, allowing for the passage of guidewires, catheters, or other devices. This introducer catheter is crucial in procedures requiring precise vascular access.
Clinical Applications
Commonly used in interventional radiology, the Teleflex Medical Introducer Catheter is essential for procedures like embolization, where precise delivery of embolic agents is required. It is also used in cardiology and vascular surgery for introducing devices into the bloodstream. The device is suitable for adult and pediatric patients requiring vascular interventions.
Indications for Use
The FDA indications for this device include facilitating the introduction of various medical instruments into the vascular system. It is used in patients requiring vascular access for diagnostic or therapeutic procedures.
Practical Considerations
The introducer catheter comes in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with a range of guidewires and catheters. Clinicians should be trained in vascular access techniques to ensure safe and effective use.
Related Literature
The linked study compared the performance and safety of Arrow PICC catheters with Arrowga+rd Blue Advanced Protection to unprotected PICCs. Although specific details are not available, the study likely focused on infection rates and catheter durability. Limitations include the lack of an abstract and publication year, making it difficult to assess the study's impact fully.
Frequently Asked Questions
What is the Teleflex Medical Introducer Catheter used for?
It is used for vascular access to introduce medical instruments into the bloodstream during procedures like embolization.
What specialties typically use this device?
Interventional radiologists, cardiologists, and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for facilitating the introduction of medical instruments into the vascular system for diagnostic or therapeutic procedures.
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.