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cvi 16 gauge central vein catherization system
Cardio-Vascular Innovations
Summary: The CVI 16 Gauge Central Vein Catheterization System is used for central venous access, commonly utilized 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
K863916 ↗
Decision Date
January 6, 1987
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on January 6, 1987, by Cardio-Vascular Innovations. It is classified as a Class 2 medical device under product code DQY.
What It Is
The CVI 16 Gauge Central Vein Catheterization System is a medical device designed for the insertion of a catheter into a central vein, typically the subclavian, internal jugular, or femoral veins. This system allows for the administration of medications, fluids, and parenteral nutrition, as well as the measurement of central venous pressure. The 16-gauge size indicates a balance between flow rate and ease of insertion, making it suitable for a variety of clinical scenarios.
Clinical Applications
This device is commonly used in intensive care units, emergency departments, and during surgical procedures. It is essential for patients requiring long-term intravenous therapy, hemodynamic monitoring, or rapid fluid resuscitation. The system is particularly useful in patients with difficult peripheral venous access or those requiring multiple infusions simultaneously.
Indications for Use
The FDA-cleared indications suggest that this device is intended for patients needing central venous access for the administration of medications, fluids, or for monitoring purposes. It is suitable for both adult and pediatric patients, depending on the clinical scenario.
Practical Considerations
The 16-gauge size is a common choice for balancing flow rate and ease of insertion. Clinicians should be familiar with ultrasound-guided techniques to improve insertion success rates and reduce complications. Compatibility with standard central line kits and accessories should be verified prior to use.
Frequently Asked Questions
What is the CVI 16 Gauge Central Vein Catheterization System used for?
It is used for central venous access to administer medications, fluids, and for hemodynamic monitoring.
What specialties typically use this device?
This device is commonly used by intensivists, anesthesiologists, emergency medicine physicians, and surgeons.
What are the FDA-cleared indications?
The device is indicated for central venous access for medication administration, fluid resuscitation, and monitoring of central venous pressure.
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.