đź“‹ FDA Reference
7 french dual lumen com cent vein cath sys
Cardio-Vascular Innovations
Summary: The 7 French Dual Lumen Central Venous Catheter System is a medical device used for central venous access, primarily by healthcare professionals in critical care and surgical settings. It facilitates the administration of medications, fluids, and the monitoring of central venous pressure.
FDA Clearance Information
Pathway
510K
Number
K852791 ↗
Decision Date
November 5, 1985
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on November 5, 1985, by Cardio-Vascular Innovations. It is classified as a Class 2 device under product code DQY.
What It Is
The 7 French Dual Lumen Central Venous Catheter System is designed for central venous access, featuring two lumens that allow for simultaneous administration of medications and fluids. It is typically inserted into a large central vein, such as the subclavian or internal jugular vein, and is used for both short-term and long-term vascular access. The dual lumen design provides versatility in managing complex patient needs.
Clinical Applications
This catheter system is commonly used in intensive care units, operating rooms, and emergency settings. It is essential for patients requiring central venous pressure monitoring, rapid fluid resuscitation, or administration of vasoactive drugs. It is particularly useful in managing critically ill patients, those undergoing major surgery, or patients with difficult peripheral venous access.
Indications for Use
The device is indicated for patients needing central venous access for the administration of medications, fluids, or for central venous pressure monitoring. It is suitable for use in patients who require long-term intravenous therapy or have poor peripheral venous access.
Practical Considerations
The 7 French size is typical for adult patients, providing a balance between ease of insertion and sufficient flow rates. It is compatible with standard central venous catheter insertion kits and techniques. Clinicians should be trained in sterile insertion techniques to minimize infection risk.
Frequently Asked Questions
What is the 7 French Dual Lumen Central Venous Catheter System used for?
It is used for central venous access to administer medications, fluids, and for monitoring central venous pressure.
What specialties typically use this device?
This device is commonly used by intensivists, anesthesiologists, and emergency medicine physicians.
What are the FDA-cleared indications?
The device is indicated for central venous access for medication and fluid administration and central venous pressure monitoring.
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.