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 ?
510(k)
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.
FDA-Cleared Indications
- Vascular access for procedures requiring placement of embolization coils.
- Use in interventional procedures where a catheter must be split and removed after embolic-device deployment.
Clinical Applications
- Catheter-based delivery of embolization coils to selected blood vessels.
- Embolization of aneurysms or pseudoaneurysms when coil placement is indicated.
- Treatment of active or potential bleeding when transcatheter coil embolization is indicated.
- Vascular embolization procedures performed by interventional radiology, vascular surgery, or neurointerventional teams.
Practical Considerations
- The catheter is available in different sizes and configurations; the appropriate size depends on the access vessel, target anatomy, and embolization device.
- Use requires image guidance, typically fluoroscopy with contrast, and careful positioning before coil deployment.
- Clinicians must understand the splitable mechanism and follow the manufacturer’s instructions to avoid catheter displacement or unintended embolization.
- MRI safety and conditional-use information depends on the specific catalog number and materials; verify the current labeling before MRI.
- Contraindications and precautions include inability to obtain safe vascular access, severe contrast allergy when contrast is required, uncorrectable coagulopathy, and infection at the access site, as clinically applicable.
Procedures that use this device
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.