📋 FDA Reference
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 ?
510(k)
Number ?
K870675 ↗
Decision Date ?
April 9, 1987
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Percutaneous insertion of a catheter into a blood vessel to establish venous access.
- Use during procedures requiring catheter access for the administration of fluids, medications, or other prescribed therapies.
- Use for diagnostic or therapeutic vascular access in accordance with the device labeling and institutional protocols.
Clinical Applications
- Preparing for and performing percutaneous venous catheter placement.
- Establishing venous access for intravenous fluids or medications.
- Supporting vascular access during hospital, intensive care, emergency, or surgical care.
- Providing components needed for catheter insertion under standard sterile technique.
Practical Considerations
- The record identifies a 13 French catheter with a 4 cm length; clinicians should verify the exact configuration, components, and catalog information before use.
- Use only with compatible catheters, guidewires, needles, syringes, and other accessories specified by the product labeling or institutional protocol.
- Insertion should be performed by trained personnel using appropriate sterile technique and, when indicated, ultrasound or other imaging guidance.
- The supplied information does not establish MRI safety. Confirm the MRI labeling for the complete system and any implanted or retained components before MRI.
- Contraindications and precautions depend on the access site, catheter system, patient anatomy, infection or bleeding risk, and the current manufacturer instructions for use.
Procedures that use this device
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.