# K092205: Palindrome P Hemodialysis Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Covidien Lp, Formerly Registered AS Kendall
- Decided: Oct 30, 2009 after 100 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K010399 (2001). 3 ancestors in all.
11 later devices descend from it; 2 cite it directly.
3 of 15 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.
- K040078: Cannon II Plus, Arrow International, Inc. (2004) Summary page 1.

## Most influential descendants
- K111372: Tal Pallindrome (TM) Symmetric Tip Dual Lumen Catheter, Mahurkar (R) Maxid (TM) Dual Lumen Catheter, Palindrome (TM)... (2011), 10 descendants of its own
- 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

## Indications for use
The Palindrome Reverse Tunneled Catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters greater than 40 cm implant length are indicated for femoral insertion. The Palindrome reverse-tunneled catheter repair kit is intended for the repair of the hub/back end assembly (extension tubing, luer adapter(s) or clamp(s)) or to repair the hub snap connector component(s). A repair can only be made if the tubing length between the hub snap connector and the exit sit is a minimum of 5.5 cm

Source page: https://510kreport.com/device/K092205
Methodology: https://510kreport.com/methodology