đź“‹ FDA Reference
Mac Two-Lumen Central Venous Kit with Arrowg Ard Blue Antimicrobial Surface and Integral Hemostasis Valve Side Port
Arrow Intl.
Summary: The mac two-lumen central venous kit with Arrowg+ard Blue is used for central venous access, providing antimicrobial protection. It is typically used by anesthesiologists and critical care specialists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K011761 ↗
Decision Date ?
October 31, 2001
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The mac two-lumen central venous kit was cleared through the FDA 510(k) pathway on October 31, 2001. Manufactured by Arrow Intl., it is a Class 2 medical device.
What It Is
This device is a central venous catheter kit designed for vascular access. It features two lumens, allowing for simultaneous infusion of medications and fluids. The Arrowg+ard Blue antimicrobial surface helps reduce infection risk, and the integral hemostasis valve side port aids in maintaining hemostasis during use.
FDA-Cleared Indications
- Central venous access for administration of fluids, medications, blood products, or other compatible solutions.
- Central venous access for monitoring central venous pressure or other hemodynamic parameters.
- Use when simultaneous central venous infusion, aspiration, or monitoring is clinically required.
Clinical Applications
- Central venous access during major surgery and anesthesia.
- Administration of medications, fluids, and blood products in critical care.
- Central venous pressure and hemodynamic monitoring.
- Simultaneous infusion or aspiration through separate catheter lumens.
Practical Considerations
- The kit is available in different catheter sizes and configurations; selection depends on the patient’s anatomy, intended flow requirements, and clinical use.
- Insertion is generally performed using sterile technique with ultrasound and imaging guidance when appropriate. Common access sites include the internal jugular, subclavian, or femoral vein.
- The catheter must be used only with compatible fluids, medications, syringes, and infusion equipment according to the manufacturer’s instructions.
- The Arrowg+ard Blue surface is intended to help reduce microbial colonization; it does not eliminate the risk of central-line infection.
- MRI safety depends on the specific catheter configuration and labeling. Confirm the exact model’s MR Safe, MR Conditional, or MR Unsafe status before an MRI examination.
Procedures that use this device
Frequently Asked Questions
What is the mac two-lumen central venous kit used for?
It is used for central venous access to administer medications, fluids, and for hemodynamic monitoring.
What specialties typically use this device?
Anesthesiology, critical care, and emergency medicine specialists commonly use this device.
What are the FDA-cleared indications?
It is cleared for use in patients requiring central venous access for medication delivery, fluid management, and 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.