14 Fr Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg Ard Blue Catheter for High Volume Infusions Pro
Arrow Intl.
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FDA Clearance Information
This device was cleared through the FDA 510(k) pathway on September 14, 2000. Manufactured by Arrow Intl., it is classified as a Class 2 device under product code MPB.
What It Is
FDA-Cleared Indications
- Temporary central venous access for hemodialysis.
- High-volume infusion or withdrawal of blood through a non-implanted hemodialysis catheter.
Clinical Applications
- Providing temporary vascular access for hemodialysis in patients who need dialysis.
- Connecting a dialysis circuit to the venous circulation through two catheter lumens.
- Supporting high-flow blood withdrawal and return during dialysis treatment.
- Use in hospital or dialysis settings when short-term central venous access is required for the labeled application.
Reported off-label uses
- Temporary high-flow access for selected extracorporeal blood purification procedures other than the labeled dialysis application, when determined appropriate by the treating clinician.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- The 14 French size is relatively large and is generally selected when high blood-flow rates are needed; catheter size must be matched to the patient's vessel size and clinical needs.
- This is a two-lumen, non-implanted catheter intended for temporary access, not a permanent dialysis access such as an arteriovenous fistula or graft.
- Placement should use sterile technique and appropriate imaging guidance, commonly ultrasound for venous access and fluoroscopy or other imaging to confirm tip position.
- MRI compatibility depends on the exact catheter and kit components. The product labeling should be checked before MRI; do not assume the catheter is MR Safe or MR Conditional.
- Potential complications include bleeding, infection, thrombosis, arterial puncture, air embolism, catheter malposition, vessel injury and inadequate flow. Contraindications and precautions should be reviewed in the manufacturer's instructions for use.
Frequently Asked Questions
What is the 14 fr two-lumen hemodialysis catheter used for?
It is used for high-volume blood infusions in hemodialysis, providing reliable vascular access for patients with kidney failure.
What specialties typically use this device?
Nephrologists and dialysis nurses primarily use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
It is indicated for patients needing high-volume blood infusions, such as those undergoing hemodialysis due to kidney failure.