📋 FDA Reference
Enlightn Renal Guide Catheter
Summary: The enlightn renal guide catheter is a medical device used in vascular procedures, primarily by interventional radiologists and cardiologists, to assist in the placement of stents in renal arteries. It is designed for use in patients requiring renal artery intervention.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K131592 ↗
Decision Date ?
January 31, 2014
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The enlightn renal guide catheter was cleared through the FDA 510(k) pathway on January 31, 2014. Manufactured by St. Jude Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The enlightn renal guide catheter is a specialized catheter designed to facilitate the delivery of stents to the renal arteries. It provides support and guidance during endovascular procedures, ensuring precise placement of stents. The catheter is engineered to navigate the vascular anatomy with flexibility and stability, which is crucial for successful renal interventions.
FDA-Cleared Indications
- Percutaneous catheterization of the renal arteries during endovascular procedures.
- Guidance and support for the delivery of interventional devices in the renal arteries.
- Use by trained clinicians according to the device labeling, applicable anatomy, and procedural requirements.
Clinical Applications
- Selective renal artery catheterization.
- Guide support during endovascular treatment of renal artery disease when an interventional device is indicated.
- Support for delivery and positioning of a renal artery stent or other compatible device.
- Use during image-guided renal artery interventions performed through percutaneous vascular access.
Practical Considerations
- The device is intended for use by clinicians trained in percutaneous vascular and endovascular techniques.
- Available sizes, working length, guidewire compatibility, and other specifications should be confirmed in the current manufacturer instructions for use.
- Use fluoroscopic or other appropriate imaging guidance and handle the catheter carefully to reduce the risk of vessel injury, dissection, spasm, thrombosis, or embolization.
- MRI safety and conditional use should be verified in the current labeling; do not assume the catheter is safe for MRI based only on its name.
- Contraindications, warnings, and compatibility with stents, guidewires, introducer sheaths, contrast agents, and other equipment should be reviewed before use.
Frequently Asked Questions
What is the enlightn renal guide catheter used for?
It is used to assist in the placement of stents in the renal arteries, particularly in patients with renal artery stenosis.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device during vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in renal artery interventions, particularly for placing stents to treat conditions like renal artery stenosis.
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.