# K071422: 15.5F Hemo-Stream Hemodialysis Catheter Set

- Pathway: 510(k) (Traditional)
- Applicant: Rex Medical
- Decided: Aug 22, 2007 after 92 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 K012365 (2001). 3 ancestors in all.
5 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)
- K023847: Hemo-Stream Hemodialysis Catheter Set, Rex Medical (2003) Summary page 1.
- K040736: Vaxcel Plus Chronic Dialysis Catheter, Boston Scientific Corp (2004) Summary page 1.
- K012365: Vaxcel Dialysis Catheter, Boston Scientific Corp (2001) Summary page 1.

## Most influential descendants
- K102043: Ultrastream Chronic Hemodialysis Catheter (2010), 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
- 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 Hemo-StreamTM True Over the Wire Dialysis Catheter is designed for chronic hemodialysis and apheresis.

Source page: https://510kreport.com/device/K071422
Methodology: https://510kreport.com/methodology