📋 FDA Reference

14 Fr Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg Ard Blue Catheter for High Volume Infusions Pro

Arrow Intl.

Product: Arrow — all models and sizes · Where to buy · Find similar guidewires by size

Compare similar devices

Summary: The 14 fr two-lumen hemodialysis catheter by Arrow Intl. is used for high-volume infusions in dialysis. It is typically utilized by nephrologists and other healthcare professionals in dialysis centers and hospitals.

FDA Clearance Information

Pathway ? 510(k)
Number ? K993933 ↗
Decision Date ? September 14, 2000
Product Code ? MPB Catheter, Hemodialysis, Non-Implanted
Device Class ? Class 2
Evidence ? 0 studies

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

The 14 fr two-lumen hemodialysis catheter is a medical device designed for high-volume blood infusions and dialysis. It features a blue flextip for ease of insertion and reduced trauma to the vessel. The catheter is part of a kit that includes necessary components for catheterization, facilitating efficient and safe vascular access.

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.

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.

📬 The IR Device Brief

One email a month: new FDA clearances, recalls and device pages in vascular & interventional radiology.

We'll email you a link to confirm. Unsubscribe any time.

Suggest edits

For manufacturers and their teams. Each field shows what the page says now: add, remove or rewrite anything, and leave the rest as is. LA Vascular reviews every change before it goes live.

About you