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selectsite c304 deflectable catheter system c315 delivery system
Medtronic
Summary: The SelectSite C304 Deflectable Catheter System by Medtronic is used for the delivery of venous stents. It is primarily utilized by interventional cardiologists and radiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K223178 ↗
Decision Date
November 8, 2022
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The SelectSite C304 Deflectable Catheter System, manufactured by Medtronic, received FDA clearance through the 510(k) pathway on November 8, 2022. It is a Class 2 device under product code DQY.
What It Is
The SelectSite C304 Deflectable Catheter System is a specialized medical device designed to aid in the placement of venous stents. It features a deflectable tip that allows for precise navigation through the venous system, enhancing the ability to reach target sites with accuracy. This system is particularly useful in complex anatomical scenarios where traditional catheters may struggle.
Clinical Applications
This catheter system is commonly used in procedures involving venous stenting, such as treating venous obstructions or insufficiencies. It is often employed in interventional cardiology and radiology departments, where clinicians need to navigate through challenging venous pathways. The device is suitable for adult patients requiring venous interventions, particularly those with complex vascular anatomies.
Indications for Use
The FDA-cleared indications for this device include its use in delivering venous stents to treat conditions like venous obstructions. It is intended for patients who require precise stent placement in the venous system.
Practical Considerations
Clinicians should be aware of the catheter's compatibility with various stent sizes and ensure proper technique in manipulating the deflectable tip. Familiarity with the device's handling characteristics can enhance procedural success and reduce complications.
Frequently Asked Questions
What is the SelectSite C304 Deflectable Catheter System used for?
It is used for delivering venous stents in patients with venous obstructions or insufficiencies.
What specialties typically use this device?
Interventional cardiologists and radiologists primarily use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for the delivery of venous stents to treat venous obstructions.
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.