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curity percutaneous catheter insertion tray
The Kendal
Summary: The Curity Percutaneous Catheter Insertion Tray is a medical device used for the insertion of catheters into the body. It is primarily used by healthcare professionals in hospital settings for patients requiring catheterization.
FDA Clearance Information
Pathway
510K
Number
K855060 ↗
Decision Date
April 16, 1986
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Curity Percutaneous Catheter Insertion Tray was cleared by the FDA through the 510(k) pathway on April 16, 1986. Manufactured by The Kendal, it is classified as a Class 2 device under product code DYB.
What It Is
The Curity Percutaneous Catheter Insertion Tray is a pre-packaged kit containing all necessary components for the sterile insertion of a catheter into the body. This device facilitates the placement of catheters, which are used to drain fluids, administer medications, or access the vascular system. The tray is designed to streamline the catheterization process, ensuring sterility and efficiency.
Clinical Applications
This device is commonly used in hospital settings, particularly in departments such as interventional radiology, cardiology, and critical care. It is utilized in procedures requiring vascular access, such as central venous catheterization or the insertion of PICC lines. The tray is suitable for adult and pediatric patients who require long-term intravenous therapy or monitoring.
Indications for Use
The FDA-cleared indications for this device include the insertion of catheters for patients needing vascular access. It is used in conditions requiring intravenous medication administration, fluid management, or hemodynamic monitoring.
Practical Considerations
The Curity Percutaneous Catheter Insertion Tray typically includes various sizes of catheters to accommodate different patient needs. It is compatible with standard catheterization techniques and is designed for single-use to maintain sterility. Clinicians should ensure proper technique to minimize the risk of infection.
Frequently Asked Questions
What is the Curity Percutaneous Catheter Insertion Tray used for?
It is used for the sterile insertion of catheters into the body for vascular access, fluid management, or medication administration.
What specialties typically use this device?
Specialties such as interventional radiology, cardiology, and critical care commonly use this device.
What are the FDA-cleared indications?
The device is indicated for the insertion of catheters in patients requiring vascular access for intravenous therapy or 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.