# K060509: Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating

- Pathway: 510(k) (Traditional)
- Applicant: Tyco Healthcare Group
- Decided: Jun 23, 2006 after 116 days
- Product code: NYU (Catheter, Hemodialysis, Implanted, Coated)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K974236 (1999). 4 ancestors in all.
7 later devices descend from it; 2 cite it directly.
2 of 12 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.
- K991320: Medcomp Duo-Flow II Catheter with Lubricious Heparin, Medical Components, Inc. (1999) Summary page 1.
- K973760: Affinity Hollow Fiber Oxygenator with Trillium Biopassive Surface, Avecor Cardiovascular, Inc. (1998) Summary page 1.

## Most influential descendants
- K062671: 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome Sapphire) (2006), 6 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
- K171618: Symetrex Long Term Hemodialysis Catheter (2017), 2 descendants of its own

## Recalls of this device
- Sep 19, 2008 · Not classified · Z-0408-2009: Incorrect size of the Venetrac stylets (an optional accessory). They are too short and cannot be used.
- Sep 19, 2008 · Not classified · Z-0409-2009: Incorrect size of the Venetrac stylets (an optional accessory). They are too short and cannot be used.
- Sep 19, 2008 · Not classified · Z-0411-2009: Incorrect size of the Venetrac stylets (an optional accessory). They are too short and cannot be used.
- Sep 19, 2008 · Not classified · Z-0410-2009: Incorrect size of the Venetrac stylets (an optional accessory). They are too short and cannot be used.

## Indications for use
The Palindrome Emerald 14.5 fr Cuffed catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. The performance of the heparin coating on this catheter in reducing platelet adhesion on the catheter surface for up to 720 hours of dialysis treatment is supported by bench and animal testing. It may be inserted either percutaneously or by cutdown.

Source page: https://510kreport.com/device/K060509
Methodology: https://510kreport.com/methodology