📋 FDA Reference
14 Fr Hemodialysis Two-Lumen Catheterization Kit
Arrow Intl.
Product: Arrow — all models and sizes · Where to buy · Find similar guidewires by size
Summary: The 14 Fr hemodialysis two-lumen catheterization kit by Arrow Intl. is used for vascular access in hemodialysis. It is typically used by nephrologists and other healthcare professionals in dialysis centers or hospitals.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K991431 ↗
Decision Date ?
May 26, 1999
Product Code ?
MPB Catheter, Hemodialysis, Non-Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared through the FDA's 510(k) pathway on May 26, 1999. It is manufactured by Arrow Intl. and classified as a Class 2 medical device under product code MPB.
What It Is
The 14 Fr hemodialysis two-lumen catheterization kit is designed for temporary vascular access in patients requiring hemodialysis. It consists of a catheter with two lumens, allowing for simultaneous blood withdrawal and return. This device is inserted into a large central vein, typically the internal jugular, subclavian, or femoral vein, to facilitate efficient dialysis treatment.
FDA-Cleared Indications
- Temporary central venous access for hemodialysis.
- Use in patients who require hemodialysis but do not have usable permanent access, such as an arteriovenous fistula or graft.
Clinical Applications
- Hemodialysis access in patients with acute kidney injury or acute renal failure.
- Short-term dialysis access while a permanent arteriovenous fistula or graft is created or matures.
- Hospital-based hemodialysis when immediate or temporary central venous access is required.
Practical Considerations
- The catheter is 14 French and is intended for adult central venous access; the appropriate catheter length depends on the selected vein and patient anatomy.
- Common access sites include the internal jugular, femoral, and subclavian veins. Ultrasound and radiographic or other appropriate imaging confirmation may be used according to institutional practice.
- Strict sterile technique is required because central venous dialysis catheters can cause bloodstream infection, thrombosis, bleeding, arterial puncture, pneumothorax, or malposition.
- Confirm that the catheter, dialysis tubing, connectors, and dialysis machine are compatible before use. Follow the current device instructions for priming, flushing, locking, and removal.
- MRI safety cannot be determined from the FDA 510(k) record alone. Check the current manufacturer labeling for MR Safe, MR Conditional, or MR Unsafe status before an MRI examination.
Frequently Asked Questions
What is the 14 Fr hemodialysis catheter used for?
It is used for temporary vascular access in patients needing hemodialysis.
What specialties typically use this device?
Nephrologists and interventional radiologists commonly use this device in hospital and dialysis center settings.
What are the FDA-cleared indications?
The catheter is indicated for temporary vascular access in patients requiring hemodialysis.
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.