# K121933: Nexsite HD Hemodialysis Catheter for Long Term Use (28CM) Nexsite HD Hemodialysis Catheter for Long Term Use (24CM)

- Pathway: 510(k) (Traditional)
- Applicant: Marvao Medical Devices, Ltd.
- Decided: Mar 14, 2013 after 255 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: 9 generations back to K001901 (2000). 24 ancestors in all.
4 later devices descend from it; 3 cite it directly.
2 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994105: Hemo-Flow Double Lumen Catheter, Models HFS-24, HFS-28, HFS-32, HFS-36, HFS-40, Medical Components, Inc. (2001) Summary page 1.
- K110627: Nexsite 9FR Dual Lumen Critical Care Central Venous Catheter, Marvao Medical Devices, Ltd. (2011) Summary page 1.

## Most influential descendants
- K133796: Nexsite HD, Hemodialysis Catheter for Long Term Use (32CM), Nexsite HD, Hemodialysis Catheter for Long Term Use (36CM), (2014), 3 descendants of its own
- K140492: Nexsite HD (55CM), Hemodialysis Catheter for Long Term Use (2014), 2 descendants of its own
- K161026: NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm) (2016), 1 descendant of its own
- 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 H-D, Hemodialysis Catheter for tang term use is indicated far use in attaining long term vascular access far hemnodialysis 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 subelavian vein.

Source page: https://510kreport.com/device/K121933
Methodology: https://510kreport.com/methodology