# K102043: Ultrastream Chronic Hemodialysis Catheter

- Pathway: 510(k) (Special)
- Applicant: Rex Medical
- Decided: Nov 18, 2010 after 121 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K012365 (2001). 4 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071422: 15.5F Hemo-Stream Hemodialysis Catheter Set, Rex Medical (2007) Summary page 1.

## Most influential descendants
- K140884: Symetrex Long Term Hemodialysis Catheter (2014), 3 descendants of its own
- 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

## Recalls of this device
- Jun 5, 2014 · Class II · Z-2698-2014: UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.
- Jun 5, 2014 · Class II · Z-2696-2014: UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.
- Jun 5, 2014 · Class II · Z-2697-2014: UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.

## Indications for use
The UltraStreamn Chronic Hemnodialysis Catheter is designed for chronic hemodialysis and apheresis.

Source page: https://510kreport.com/device/K102043
Methodology: https://510kreport.com/methodology