# K143102: Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions

- Pathway: 510(k) (Traditional)
- Applicant: Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
- Decided: Jul 24, 2015 after 268 days
- Product code: NIE (Catheter, Hemodialysis, Triple Lumen, Non-Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K001901 (2000). 28 ancestors in all.
No later device cites it as a predicate yet.
7 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993933: 14 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+Ard Blue Catheter for High Volume Infusions, Pro, Arrow Intl., Inc. (2000) Summary page 5.
- K083675: Power-Trialysis Triple Lumen Acute Dialysis Catheter, C.R. Bard, Inc. (2009) Summary page 5.
- K973561: Medcomp Tri-Flow Soft Tip Triple Lumen Catheter 11.5F X 12CM, Medcomp Tri-Flow Soft Tip Triple Lumen Catheter 11.5F X 1M, Medical Components, Inc. (1998) Summary page 5.

## Recalls of this device
- Apr 21, 2026 · Class I · Z-2374-2026: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffect
- Dec 22, 2017 · Class II · Z-1328-2018: Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

## Indications for use
The device is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, apheresis, rapid fluid administration, intravenous therapy, blood sampling, pressure injection of contrast media, and central venous pressure monitoring. The catheter may also be used in a variety of renal replacement therapies, such as hemofiltration and hemoperfusion. The catheter may be inserted into the jugular, subclavian, or femoral veins. The maximum pressure injection flow rate is 6 mL / sec.

Source page: https://510kreport.com/device/K143102
Methodology: https://510kreport.com/methodology