# K140492: Nexsite HD (55CM), Hemodialysis Catheter for Long Term Use

- Pathway: 510(k) (Traditional)
- Applicant: Marvao Medical Devices, Ltd.
- Decided: Nov 13, 2014 after 259 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: 11 generations back to K001901 (2000). 29 ancestors in all.
2 later devices descend from it; 1 cites it directly.
2 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030502: 14.5F X 55CM Hemo-Flow Double Lumen Catheter, Models HFS-55, HFT-55, Medcomp (2003) Summary page 4.
- 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.

## Most influential descendants
- 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™ HD, Hemodialysis Catheter for long term use is indicated for use in attaining long term vascular access for chronic hemodialysis and apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein. Catheters greater than 40cm long are intended for femoral vein insertion.

Source page: https://510kreport.com/device/K140492
Methodology: https://510kreport.com/methodology