đź“‹ FDA Reference
selectsite c304 deflectable catheter system c304 c315 delivery system c315
Medtronic
Summary: The SelectSite C304/C315 is a deflectable catheter system used primarily for venous stent delivery. It is used by interventional cardiologists and vascular specialists to navigate and place stents in venous pathways.
FDA Clearance Information
Pathway
510K
Number
K250558 ↗
Decision Date
March 27, 2025
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The SelectSite C304/C315 received FDA clearance via the 510(k) pathway on March 27, 2025. Manufactured by Medtronic, it is classified as a Class 2 medical device.
What It Is
The SelectSite C304/C315 is a deflectable catheter system designed for precise navigation and delivery of venous stents. It features a flexible, steerable tip that allows clinicians to maneuver through complex venous anatomy. The catheter system is compatible with a range of stent sizes, offering versatility in treating various venous conditions.
Clinical Applications
This device is commonly used in interventional cardiology and vascular surgery settings for procedures involving venous stenting. It is particularly useful in cases requiring precise placement of stents in challenging venous pathways, such as in patients with chronic venous insufficiency or post-thrombotic syndrome. The device is typically used in hospital catheterization labs by trained specialists.
Indications for Use
The SelectSite C304/C315 is indicated for use in patients requiring venous stent placement. It is suitable for conditions where venous obstruction or narrowing is present, helping to restore proper blood flow.
Practical Considerations
The catheter system is available in various sizes to accommodate different patient anatomies and stent types. It is important to ensure compatibility with the stents being used and to follow specific technique guidelines for optimal results. Proper training in the use of deflectable catheters is recommended.
Frequently Asked Questions
What is SelectSite C304/C315 used for?
The SelectSite C304/C315 is used for the delivery and placement of venous stents in patients with venous obstructions.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in delivering venous stents to treat conditions like venous obstructions or narrowing.
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.