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enlightn renal guide catheter
St. Jude Medical
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
510K
Number
K131592 ↗
Decision Date
January 31, 2014
Product Code
DQY
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.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings for procedures involving renal artery stenosis. It is particularly useful in patients with hypertension due to renal artery blockages. The catheter aids in the accurate placement of stents, which is essential in restoring proper blood flow and reducing hypertension-related complications.
Indications for Use
The enlightn renal guide catheter is indicated for use in patients requiring intervention in the renal arteries, typically due to conditions like renal artery stenosis. It is designed to assist in the placement of stents, which can help alleviate symptoms associated with reduced blood flow to the kidneys.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard vascular access equipment and requires careful handling to ensure optimal performance. Clinicians should be familiar with endovascular techniques to maximize the device's effectiveness.
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.