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american pharmaseal triple lumen catheter
American Pharmaseal Div. Ahsc
Summary: The American Pharmaseal Triple Lumen Catheter is a medical device used for venous access in various clinical settings. It is typically used by healthcare professionals for administering medications, fluids, and for blood sampling.
FDA Clearance Information
Pathway
510K
Number
K852491 ↗
Decision Date
September 25, 1985
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The American Pharmaseal Triple Lumen Catheter was cleared through the FDA 510k pathway on September 25, 1985. It is manufactured by American Pharmaseal Div. Ahsc and classified as a Class 2 medical device.
What It Is
The American Pharmaseal Triple Lumen Catheter is a multi-lumen catheter designed for venous access. It allows simultaneous administration of different medications or fluids through separate lumens, reducing the need for multiple venous punctures. This device is typically inserted into a large vein, such as the subclavian or jugular vein, and is used for both short-term and long-term intravenous therapy.
Clinical Applications
This catheter is commonly used in intensive care units, oncology, and surgical settings for patients requiring complex intravenous therapy. It is particularly useful for patients needing multiple infusions, such as chemotherapy, antibiotics, or parenteral nutrition. The device is suitable for both adult and pediatric patients, depending on the size of the catheter used.
Indications for Use
The FDA indications for this catheter include providing venous access for the administration of medications, fluids, and for blood sampling. It is intended for patients who require central venous access due to the complexity or duration of their treatment.
Practical Considerations
The triple lumen design allows for versatile use, with typical sizes ranging to accommodate different patient needs. Compatibility with standard infusion equipment is generally expected. Proper insertion technique and maintenance are crucial to minimize infection risks and ensure device longevity.
Frequently Asked Questions
What is the American Pharmaseal Triple Lumen Catheter used for?
It is used for providing central venous access to administer medications, fluids, and for blood sampling.
What specialties typically use this device?
Intensive care, oncology, and surgical specialties commonly use this catheter.
What are the FDA-cleared indications?
The catheter is indicated for providing venous access for medication administration, fluid delivery, and blood sampling.
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.