# K111817: Palindrome RT Chronic Catheter

- Pathway: 510(k) (Special)
- Applicant: Covidien
- Decided: Aug 30, 2011 after 64 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K010399 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092205: Palindrome P Hemodialysis Catheter, Covidien Lp, Formerly Registered AS Kendall (2009) Summary page 1.
- K111372: Tal Pallindrome (TM) Symmetric Tip Dual Lumen Catheter, Mahurkar (R) Maxid (TM) Dual Lumen Catheter, Palindrome (TM)..., Covidien (2011). Cleared while this submission was under review Summary page 2.

## Recalls of this device
- May 28, 2021 · Class II · Z-2368-2021: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
- May 28, 2021 · Class II · Z-2369-2021: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
- May 28, 2021 · Class II · Z-2364-2021: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
- May 28, 2021 · Class II · Z-2366-2021: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
- May 28, 2021 · Class II · Z-2358-2021: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
- May 28, 2021 · Class II · Z-2367-2021: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
- May 28, 2021 · Class II · Z-2363-2021: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
- May 28, 2021 · Class II · Z-2362-2021: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
- May 28, 2021 · Class II · Z-2370-2021: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
- May 28, 2021 · Class II · Z-2361-2021: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
- May 28, 2021 · Class II · Z-2359-2021: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
- May 28, 2021 · Class II · Z-2360-2021: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
- May 28, 2021 · Class II · Z-2365-2021: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).

## Indications for use
The PalindromeTM RT Chronic Catheter is intended for acute and chronic hemodialysis, apheresis, and infusion, It may be inserted either percutaneously or by cut down. Catheters with greater than 40 cm implant length are indicated for femoral insertion.

Source page: https://510kreport.com/device/K111817
Methodology: https://510kreport.com/methodology