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pharmacia deltec subclavian introducers
Deltec Systems
Summary: The Pharmacia Deltec Subclavian Introducers are medical devices used to facilitate the insertion of catheters into the subclavian vein. They are primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K871132 ↗
Decision Date
April 20, 1987
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Pharmacia Deltec Subclavian Introducers were cleared through the FDA 510(k) pathway on April 20, 1987. Manufactured by Deltec Systems, this Class 2 device is categorized under product code DYB.
What It Is
The Pharmacia Deltec Subclavian Introducers are specialized medical devices designed to aid in the insertion of catheters into the subclavian vein. These introducers provide a stable and secure entry point, minimizing the risk of vessel trauma during catheterization. Their design typically includes a needle, dilator, and sheath, which work together to ensure smooth and efficient catheter placement.
Clinical Applications
These introducers are commonly used in procedures requiring central venous access, such as the placement of central venous catheters for long-term medication administration, dialysis, or parenteral nutrition. They are frequently utilized in hospital settings, particularly in intensive care units and surgical departments, and are used by specialists in interventional radiology, vascular surgery, and critical care medicine.
Indications for Use
The FDA indications for the Pharmacia Deltec Subclavian Introducers include facilitating catheter insertion into the subclavian vein. This is particularly relevant for patients requiring central venous access for treatments such as chemotherapy, dialysis, or intravenous nutrition.
Practical Considerations
When using the Pharmacia Deltec Subclavian Introducers, clinicians should be aware of the typical sizes available to match patient anatomy and the specific catheter being used. Compatibility with various catheter types should be confirmed, and practitioners should be skilled in the Seldinger technique for safe and effective use.
Frequently Asked Questions
What is Pharmacia Deltec Subclavian Introducers used for?
They are used to facilitate the insertion of catheters into the subclavian vein for central venous access.
What specialties typically use this device?
Interventional radiologists, vascular surgeons, and critical care specialists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for facilitating catheter insertion into the subclavian vein, particularly for patients needing central 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.