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mallinckrodt medical inc infussion catherter
Mallinckrodt Medical
Summary: The Mallinckrodt Medical infusion catheter is a device used for delivering fluids directly into the venous system. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K903330 ↗
Decision Date
October 23, 1990
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The infusion catheter by Mallinckrodt Medical was cleared through the FDA 510k pathway on October 23, 1990. It is a Class 2 device under product code DQY.
What It Is
This infusion catheter is a medical device designed to deliver fluids, medications, or contrast agents directly into the venous system. It is typically used in procedures requiring precise fluid administration. The catheter is inserted into a vein and can be guided to the desired location using imaging techniques.
Clinical Applications
Commonly used in interventional radiology and vascular surgery, this catheter is essential for procedures such as angiography, chemotherapy, and fluid resuscitation. It is particularly useful in hospital settings, especially for patients requiring long-term intravenous therapy or those with difficult venous access.
Indications for Use
The FDA indications suggest this device is for patients needing direct venous access for fluid or medication delivery. It is suitable for conditions requiring precise and controlled infusion, such as during diagnostic imaging or therapeutic interventions.
Practical Considerations
Clinicians should consider the catheter's compatibility with other devices and its appropriate sizing for the patient's vasculature. Proper technique during insertion is crucial to minimize complications like thrombosis or infection.
Frequently Asked Questions
What is the infusion catheter used for?
It is used for delivering fluids, medications, or contrast agents directly into the venous system.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for patients needing direct venous access for fluid or medication delivery.
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.