# K120674: Mahurkar Elite Acute Dual Lumen Catheter, Elite Acute Triple Lumen Catheter

- Pathway: 510(k) (Special)
- Applicant: Covidien
- Decided: Apr 4, 2012 after 30 days
- Product code: MPB (Catheter, Hemodialysis, Non-Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K001901 (2000). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
5 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030209: Mahurkar Oplus Catheter, Model 13.5 FR, The Kendall Company (2003) Summary page 1.
- K102605: Mahurkar Triple Lumen Dialysis Catheter, Covidien, LLC, Formerly Registered AS Tyco Healthca (2010) Summary page 1.

## Most influential descendants
- K200426: Acute Dual Lumen Hemodialysis Catheter (2020), 0 descendants of its own

## Recalls of this device
- Apr 29, 2026 · Class II · Z-2319-2026: The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.
- Oct 14, 2017 · Class II · Z-1007-2018: Medtronic is voluntarily recalling one lot of its MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays, Lot 1717900160, following notification from our sup

## Indications for use
The MahurkarTM Elite Acute Dual Lumnen Catheter is indicated for shodt-term central venous access for hemodialysis, apheresis, and infusion. The MahurkarTm Elite Acute Triple Lumnen Catheter is indicated for shodt-term central venous access for hemodialysis, apheresis, infusion, central venous pressure monitoring, and pressure injection of contrast media. The maximum recommended infuision rate is 5 mt/sec for power injection of contrast media.

Source page: https://510kreport.com/device/K120674
Methodology: https://510kreport.com/methodology