📋 FDA Reference
5 5 F Worley Advanced Lvi Lateral Vein Introducer
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Summary: The 5 5 F Worley Advanced LVI Lateral Vein Introducer is a medical device used for the introduction of catheters into the lateral veins. It is primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K152116 ↗
Decision Date ?
August 27, 2015
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The 5 5 F Worley Advanced LVI Lateral Vein Introducer, manufactured by Merit Medical Systems, received FDA clearance via the 510(k) pathway on August 27, 2015. It is classified as a Class 2 device under product code DYB.
What It Is
The 5 5 F Worley Advanced LVI Lateral Vein Introducer is a specialized tool designed to facilitate the insertion of catheters into lateral veins, particularly in cardiac procedures. It features a flexible design to navigate the vascular system efficiently. This device is crucial in procedures requiring precise catheter placement, offering enhanced control and access to targeted vein sites.
FDA-Cleared Indications
- Introduction of catheters into lateral veins.
- Access and support for catheter placement in the cardiac venous system when lateral-vein access is required.
Clinical Applications
- Introducing catheters into lateral cardiac veins.
- Supporting catheter placement during procedures requiring access to the coronary venous system.
- Facilitating placement of cardiac leads or other catheters when lateral-vein access is needed, consistent with the device labeling.
Practical Considerations
- The device is identified as a 5.5 F introducer; clinicians should confirm the exact size and configuration before use.
- Compatibility with the intended catheter, guidewire and other procedural equipment should be verified before insertion.
- The introducer is advanced under appropriate imaging guidance by trained clinicians, with care to reduce the risk of venous injury, bleeding, arrhythmia or other vascular complications.
- The available FDA record and provided labeling summary do not establish MRI safety; MRI conditions should be confirmed in the current manufacturer instructions for use.
- Contraindications, warnings, sterilization information and dwell-time limits should be taken from the current manufacturer labeling rather than inferred from the 510(k) record.
Frequently Asked Questions
What is the 5 5 F Worley Advanced LVI Lateral Vein Introducer used for?
It is used for the introduction of catheters into lateral veins, particularly in cardiac procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for introducing catheters into lateral veins, particularly in cardiac procedures requiring precise 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.