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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
510K
Number
K831807 ↗
Decision Date
July 18, 1983
Product Code
DQY
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.
Clinical Applications
These trays are commonly used in hospital and clinical settings for procedures requiring venous access, such as intravenous therapy, blood sampling, and central venous catheterization. They are utilized by healthcare professionals in specialties such as anesthesiology, emergency medicine, and intensive care. The trays help reduce the risk of infection and improve procedural efficiency.
Indications for Use
The FDA-cleared indications for these trays include facilitating the sterile insertion of catheters for patients requiring venous access. This is applicable to a wide range of conditions where intravenous therapy or monitoring is necessary.
Practical Considerations
Catheter insertion trays come in various sizes to accommodate different patient needs and catheter types. They are compatible with standard catheterization techniques and are designed for single-use to maintain sterility. Clinicians should ensure they select the appropriate tray size based on the specific procedure and patient requirements.
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.