# K161026: NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm)

- Pathway: 510(k) (Traditional)
- Applicant: Marvao Medical Devices, Ltd.
- Decided: Aug 9, 2016 after 119 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: 12 generations back to K001901 (2000). 31 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121933: Nexsite HD Hemodialysis Catheter for Long Term Use (28CM) Nexsite HD Hemodialysis Catheter for Long Term Use (24CM), Marvao Medical Devices, Ltd. (2013) Summary page 4.
- K133796: Nexsite HD, Hemodialysis Catheter for Long Term Use (32CM), Nexsite HD, Hemodialysis Catheter for Long Term Use (36CM),, Marvao Medical Devices, Ltd. (2014) Summary page 4.
- K140492: Nexsite HD (55CM), Hemodialysis Catheter for Long Term Use, Marvao Medical Devices, Ltd. (2014) Summary page 4.
- K143567: NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (28cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (32cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (36cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (40cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (55cm), Marvao Medical Devices, Ltd. (2015) Summary page 4.

## Most influential descendants
- K173805: NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm) (2018), 0 descendants of its own

## Indications for use
The NexSite HD Hemodialysis Step Tip Catheter for long term use is indicated for use in attaining long term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is primarily inserted in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein. Catheters greater than 40cm are indicated for femoral vein insertion.

Source page: https://510kreport.com/device/K161026
Methodology: https://510kreport.com/methodology