# K102605: Mahurkar Triple Lumen Dialysis Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC, Formerly Registered AS Tyco Healthca
- Decided: Dec 22, 2010 after 103 days
- Product code: NIE (Catheter, Hemodialysis, Triple Lumen, Non-Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 26 (25 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). 24 ancestors in all.
7 later devices descend from it; 4 cite it directly.
4 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020089: Mahurkar Triple Lumen Catheter, 12 FR, The Kendall Company (2002) Summary page 1.
- K083675: Power-Trialysis Triple Lumen Acute Dialysis Catheter, C.R. Bard, Inc. (2009) Summary page 1.

## Most influential descendants
- K123292: T3 (2013), 2 descendants of its own
- K183219: Trio-CT Triple Lumen Catheter (2019), 1 descendant of its own
- K120674: Mahurkar Elite Acute Dual Lumen Catheter, Elite Acute Triple Lumen Catheter (2012), 1 descendant of its own
- K232945: Trio-CT­® Triple Lumen Catheter w/ Curved Extensions (2023), 0 descendants of its own
- K222170: Power Acute Triple Lumen Hemodialysis Catheter (2023), 0 descendants of its own

## Recalls of this device
- Jun 28, 2023 · Class I · Z-2377-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2367-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2382-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2386-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2381-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2372-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2370-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2389-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2383-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2369-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2373-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2385-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2378-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2374-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2375-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2376-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2387-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2368-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2391-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2390-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2380-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2388-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2371-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2384-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2379-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Apr 29, 2019 · Class II · Z-1955-2019: The priming volume values printed on the MAHURKA and Argyle acute catheters and Instructions for Use (IFU) are higher than the volumes required to fill each lumen.

## Indications for use
The MAHURKAR™ Triple Lumen Catheter is intended for short term central venous access for hemodialysis, apheresis, infusion, central venous pressure monitoring and pressure injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.

Source page: https://510kreport.com/device/K102605
Methodology: https://510kreport.com/methodology