# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Marvao Medical Devices, Ltd.
- Decided: Feb 8, 2018 after 55 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K001901 (2000). 33 ancestors in all.
No later device cites it as a predicate yet.
2 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161026: NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm), Marvao Medical Devices, Ltd. (2016) Summary page 4.
- K171571: NexSite HD, Hemodialysis Step Tip Catheter (60cm), Marvao Medical Devices, Ltd. (2017) Summary page 4.

## Recalls of this device
- Feb 11, 2020 · Class II · Z-1699-2021: The action is to ensure consistency between the Directions for Use (DFU) in the field and the DFU on the website.

## Indications for use
The NexSite™ HD, Hemodialysis Symmetric Tip 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 which should only be used when no other upper extremity or chest wall options are available. Catheters greater than 40cm are indicated for femoral vein insertion.

Source page: https://510kreport.com/device/K173805
Methodology: https://510kreport.com/methodology