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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 ?
510(k)
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.
FDA-Cleared Indications
- Facilitation of catheter insertion into the subclavian vein.
- Establishment of subclavian venous access for placement of an appropriate catheter.
Clinical Applications
- Obtaining subclavian venous access for central venous catheter placement.
- Supporting placement of catheters used for prolonged intravenous therapy.
- Supporting placement of central venous catheters when reliable venous access is required in a hospital setting.
Practical Considerations
- The introducer size must match the patient’s anatomy, the intended catheter, and the required access diameter.
- Confirm catheter and component compatibility before use, including sheath, dilator, guidewire, and catheter dimensions.
- Use sterile technique and an appropriate venous access technique, commonly the Seldinger technique, under suitable clinical and imaging guidance.
- Subclavian access can cause complications such as pneumothorax, bleeding, infection, arterial puncture, thrombosis, or catheter malposition; clinicians should evaluate whether another access site is more appropriate.
- MRI safety and conditional labeling should be confirmed from the current device instructions for use and the exact components used. Do not assume MRI compatibility from the product name alone.
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.