đź“‹ FDA Reference
arrow m i s multi-lumen catheteriza
Arrow Intl.
Summary: The Arrow MIS Multi-Lumen Catheter is a medical device used for venous access, particularly in critical care settings. It is utilized by healthcare professionals such as intensivists and anesthesiologists for administering medications, fluids, and monitoring central venous pressure.
FDA Clearance Information
Pathway
510K
Number
K820648 ↗
Decision Date
April 14, 1982
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Arrow MIS Multi-Lumen Catheter was cleared through the FDA 510(k) pathway on April 14, 1982. It is manufactured by Arrow International and classified as a Class 2 device under product code DQY.
What It Is
The Arrow MIS Multi-Lumen Catheter is a multi-lumen central venous catheter designed for insertion into a large vein. It allows for simultaneous administration of medications, fluids, and the measurement of central venous pressure. The device features multiple lumens, enabling separate channels for different infusions or monitoring tasks, which is crucial in managing complex patient care.
Clinical Applications
This catheter is commonly used in intensive care units and operating rooms. It is essential for patients requiring central venous access for hemodynamic monitoring, administration of vasoactive drugs, or total parenteral nutrition. The device is particularly useful in managing critically ill patients, including those undergoing major surgeries or with severe infections.
Indications for Use
The FDA indications for this device include use in patients who need central venous access for various medical interventions. It is suitable for conditions requiring long-term intravenous therapy, such as chemotherapy or extended antibiotic treatment.
Practical Considerations
The Arrow MIS Multi-Lumen Catheter is available in various sizes to accommodate different patient anatomies and clinical needs. It is compatible with standard central venous catheter insertion techniques, and clinicians should be familiar with ultrasound-guided insertion to minimize complications.
Frequently Asked Questions
What is the Arrow MIS Multi-Lumen Catheter used for?
It is used for central venous access to administer medications, fluids, and for hemodynamic monitoring in critically ill patients.
What specialties typically use this device?
Intensivists, anesthesiologists, and other healthcare professionals in critical care and surgical settings commonly use this device.
What are the FDA-cleared indications?
The device is indicated for patients requiring central venous access for interventions such as medication administration, fluid therapy, and central venous pressure 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.