đź“‹ FDA Reference
over the needle splitable catheter w funnel locato
Teleflexmedical
Summary: The Over the Needle Splitable Catheter by Teleflexmedical is a medical device used primarily in vascular access procedures. It is typically utilized by interventional radiologists and vascular surgeons to facilitate the insertion of embolization coils.
FDA Clearance Information
Pathway
510K
Number
K920907 ↗
Decision Date
October 6, 1992
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on October 6, 1992. It is manufactured by Teleflexmedical and classified as a Class 2 device under product code DYB.
What It Is
The Over the Needle Splitable Catheter is designed to provide a reliable means of vascular access. It features a splitable design that allows for easy removal after the catheter is positioned. The funnel locator aids in precise placement, which is crucial in procedures requiring high accuracy, such as embolization.
Clinical Applications
This catheter is commonly used in interventional radiology and vascular surgery settings. It is particularly useful in procedures involving the placement of embolization coils, often used to treat aneurysms or control bleeding. The device is suitable for adult patients requiring precise vascular access.
Indications for Use
The FDA indications suggest this device is intended for use in procedures requiring vascular access for the placement of embolization coils. It is suitable for patients needing treatment for vascular abnormalities or hemorrhagic conditions.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard embolization coils and requires careful handling to ensure accurate placement. Clinicians should be familiar with the splitable mechanism to optimize its use.
Frequently Asked Questions
What is the Over the Needle Splitable Catheter used for?
It is used for vascular access in procedures involving the placement of embolization coils.
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 vascular access for embolization coil placement.
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.