đź“‹ FDA Reference
Catheter Insertion Trays Various S
American Pharmaseal Div. Ahsc
Summary: Catheter insertion trays are used to facilitate the sterile insertion of catheters, primarily by healthcare professionals in hospital settings. They are essential for procedures requiring venous access.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K831807 ↗
Decision Date ?
July 18, 1983
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The catheter insertion trays by American Pharmaseal Div. Ahsc were cleared through the FDA 510(k) pathway on July 18, 1983. They are classified as Class 2 medical devices under product code DQY.
What It Is
Catheter insertion trays are pre-packaged kits containing all necessary components for the sterile insertion of catheters. These trays typically include items such as drapes, gloves, antiseptic solutions, and the catheter itself. They are designed to streamline the preparation process, ensuring sterility and efficiency during catheterization procedures.
FDA-Cleared Indications
- Facilitation of sterile percutaneous catheter insertion
- Use in patients requiring venous access
Clinical Applications
- Preparing for percutaneous venous catheter placement
- Supporting central venous catheterization
- Supporting intravenous therapy that requires catheter access
- Supporting blood sampling through a venous catheter
- Providing sterile supplies for catheter placement in hospital and clinical settings
Practical Considerations
- Tray contents and catheter specifications vary by model; confirm that the selected tray matches the planned procedure and catheter type.
- These trays are generally intended for single use and should remain in their sterile packaging until needed.
- Use sterile technique and follow the catheter manufacturer's instructions, institutional protocols, and applicable infection-prevention guidelines.
- MRI safety depends on the individual tray components and any catheter or needle included; review the product labeling before use in or near an MRI environment.
- The tray does not eliminate procedure-related risks, including bleeding, infection, vascular injury, or complications from the catheter itself.
Procedures that use this device
Frequently Asked Questions
What is catheter insertion trays used for?
They are used to facilitate the sterile insertion of catheters for venous access in medical procedures.
What specialties typically use this device?
Specialties such as anesthesiology, emergency medicine, and intensive care commonly use these trays.
What are the FDA-cleared indications?
The trays are indicated for the sterile insertion of catheters for patients needing venous access.
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.