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additional 13 4cm french catheter insertion tray

Quinton

Summary: The additional 13 4cm French catheter insertion tray by Quinton is a medical device used for venous access procedures. It is typically utilized by healthcare professionals in settings such as hospitals and clinics.

FDA Clearance Information

Pathway 510K
Decision Date April 9, 1987
Product Code DQY
Device Class Class 2
Evidence 0 studies

This device was cleared through the FDA 510(k) pathway on April 9, 1987. Manufactured by Quinton, it is classified as a Class 2 device under product code DQY.

What It Is

The additional 13 4cm French catheter insertion tray is a medical device designed to facilitate the insertion of catheters into the venous system. It includes components necessary for catheter placement, ensuring sterility and ease of use. The device is particularly useful in procedures requiring reliable venous access, such as the administration of medications or fluids.

Clinical Applications

This device is commonly used in clinical scenarios where venous access is required, such as in emergency medicine, intensive care units, and surgical settings. It is suitable for a wide range of patient populations, including adults and pediatric patients, and is often used by specialists in internal medicine, anesthesiology, and critical care.

Indications for Use

The FDA indications suggest that this device is intended for use in patients requiring venous access for therapeutic or diagnostic purposes. It is suitable for conditions where intravenous administration of fluids or medications is necessary.

Practical Considerations

The 13 4cm French size indicates the catheter's diameter and length, making it suitable for various venous access needs. Compatibility with other medical devices should be considered, and clinicians should be familiar with insertion techniques to ensure patient safety and device efficacy.

Frequently Asked Questions

What is the additional 13 4cm French catheter insertion tray used for?

It is used for venous access procedures, allowing for the administration of medications or fluids.

What specialties typically use this device?

Specialties such as emergency medicine, anesthesiology, and critical care commonly use this device.

What are the FDA-cleared indications?

The device is indicated for patients needing venous access for therapeutic or diagnostic purposes.

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.

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