# K111372: Tal Pallindrome (TM) Symmetric Tip Dual Lumen Catheter, Mahurkar (R) Maxid (TM) Dual Lumen Catheter, Palindrome (TM)...

- Pathway: 510(k) (Special)
- Applicant: Covidien
- Decided: Aug 4, 2011 after 80 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 3 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K010399 (2001). 5 ancestors in all.
10 later devices descend from it; 4 cite it directly.
3 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043272: Pallindrome 14.5FR Chronic Hemodialysis Catheter with Slotted Symmetrical Tip, Kendall (2004) Summary page 1.
- K002901: Kendall 14.5 FR Maxid Cuffed Dual Lumen Catheter, The Kendall Company (2001) Summary page 1.
- K092205: Palindrome P Hemodialysis Catheter, Covidien Lp, Formerly Registered AS Kendall (2009) Summary page 1.

## Most influential descendants
- K112477: Palindrome H, SI, Hsi Chronic Catheter (2011), 5 descendants of its own
- K123196: Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic Catheter, Palindrome Precision Hsi Chronic Cath (2013), 4 descendants of its own
- K140884: Symetrex Long Term Hemodialysis Catheter (2014), 3 descendants of its own
- K182443: Pristine Hemodialysis Catheter (2019), 2 descendants of its own
- K171618: Symetrex Long Term Hemodialysis Catheter (2017), 2 descendants of its own

## Recalls of this device
- Aug 22, 2023 · Class II · Z-2632-2023: Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implant length; the actual catheter implant length is identifiable based upon the correct labeling on the cat
- Jun 8, 2022 · Class I · Z-1320-2022: There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use
- Jun 8, 2022 · Class I · Z-1316-2022: There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use

## Indications for use
The device is indicated for acute and chronic heinodialysis, apheresis, and infusion. It may be inserted percutaneously or by cut down. Catheters with greater than 40 cm implant length are indicated for femnoral placement.

Source page: https://510kreport.com/device/K111372
Methodology: https://510kreport.com/methodology