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pharmaseal dual lumen catheter
American Pharmaseal Div. Ahsc
Summary: The Pharmaseal Dual Lumen Catheter is a medical device used for venous access, typically in patients requiring intravenous therapy or hemodynamic monitoring. It is commonly used by healthcare professionals in hospitals and clinical settings.
FDA Clearance Information
Pathway
510K
Number
K861165 ↗
Decision Date
May 5, 1986
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Pharmaseal Dual Lumen Catheter was cleared through the FDA 510(k) pathway on May 5, 1986, by American Pharmaseal Div. Ahsc. It is classified as a Class 2 device under product code DQY.
What It Is
The Pharmaseal Dual Lumen Catheter is a specialized catheter designed to provide dual-lumen access to the venous system. This allows for simultaneous administration of medications and fluids, as well as the ability to monitor central venous pressure. The dual-lumen design enhances versatility and efficiency in patient care, particularly in critical care settings.
Clinical Applications
This device is commonly used in intensive care units, emergency departments, and surgical settings where rapid and reliable venous access is required. It is particularly useful for patients needing complex intravenous therapy, such as those receiving chemotherapy, parenteral nutrition, or undergoing major surgery. The catheter is suitable for adult and pediatric patients, depending on the specific clinical scenario.
Indications for Use
The FDA indications for the Pharmaseal Dual Lumen Catheter include use in patients who require central venous access for the administration of medications, fluids, or for hemodynamic monitoring. It is intended for use in situations where dual-lumen access is beneficial.
Practical Considerations
Clinicians should consider the appropriate catheter size based on the patient's anatomy and clinical needs. The catheter should be compatible with standard central venous access techniques and equipment. Proper aseptic technique is crucial to minimize infection risk during insertion and use.
Frequently Asked Questions
What is the Pharmaseal Dual Lumen Catheter used for?
It is used for central venous access to administer medications, fluids, and for hemodynamic monitoring.
What specialties typically use this device?
This device is typically used by intensivists, anesthesiologists, emergency medicine physicians, and other healthcare professionals in critical care settings.
What are the FDA-cleared indications?
The indications include use in patients requiring central venous access for medication administration, fluid delivery, 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.