# K140884: Symetrex Long Term Hemodialysis Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Phase One Medical
- Decided: Nov 26, 2014 after 233 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: 6 generations back to K974236 (1999). 20 ancestors in all.
3 later devices descend from it; 1 cites it directly.
3 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102043: Ultrastream Chronic Hemodialysis Catheter, Rex Medical (2010) Summary page 4.
- K123196: Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic Catheter, Palindrome Precision Hsi Chronic Cath, Covidien (2013) Summary page 4.

## Most influential descendants
- K171618: Symetrex Long Term Hemodialysis Catheter (2017), 2 descendants of its own
- K173667: 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm  Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm  Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes (2018), 1 descendant of its own
- K202176: Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes (2020), 0 descendants of its own

## Indications for use
The Symetrex Long Term Hemodialysis Catheter is a symmetric tip dual lumen catheter designed for chronic hemodialysis and apheresis. It may be inserted percutaneously or by cut down. Catheters with greater than 37cm implant length are indicated for femoral placement.

Source page: https://510kreport.com/device/K140884
Methodology: https://510kreport.com/methodology