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central vein catherization kit w without medica
Medical Surgical Concepts
Summary: The central vein catheterization kit by Medical Surgical Concepts is used for accessing central veins in patients. It is primarily used by healthcare professionals in hospital settings for procedures such as central venous pressure monitoring and medication administration.
FDA Clearance Information
Pathway
510K
Number
K870411 ↗
Decision Date
June 2, 1987
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on June 2, 1987, by Medical Surgical Concepts. It is classified as a Class 2 medical device under product code DQY.
What It Is
The central vein catheterization kit is a medical device used to gain access to central veins, such as the subclavian, jugular, or femoral veins. It typically includes a catheter, guidewire, introducer needle, and other necessary components for insertion. This kit is essential for procedures requiring central venous access, such as administering medications, fluids, or parenteral nutrition, and for monitoring central venous pressure.
Clinical Applications
This device is commonly used in critical care, anesthesiology, and emergency medicine. It is employed in settings such as intensive care units, operating rooms, and emergency departments. The kit is used for patients requiring long-term intravenous therapy, hemodynamic monitoring, or when peripheral access is not feasible.
Indications for Use
The central vein catheterization kit is indicated for patients who need central venous access for medication administration, fluid resuscitation, or hemodynamic monitoring. It is suitable for patients in critical care settings or those undergoing major surgeries.
Practical Considerations
The kit typically comes in various sizes to accommodate different patient anatomies and clinical needs. Compatibility with standard monitoring and infusion systems should be considered. Proper aseptic technique is crucial to minimize infection risk during insertion.
Frequently Asked Questions
What is the central vein catheterization kit used for?
It is used for accessing central veins to administer medications, fluids, and for monitoring central venous pressure.
What specialties typically use this device?
Specialties such as critical care, anesthesiology, and emergency medicine commonly use this device.
What are the FDA-cleared indications?
The kit is indicated for central venous access in patients requiring medication administration, fluid resuscitation, or hemodynamic 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.