# K171571: NexSite HD, Hemodialysis Step Tip Catheter (60cm)

- Pathway: 510(k) (Special)
- Applicant: Marvao Medical Devices, Ltd.
- Decided: Nov 30, 2017 after 184 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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 (60cm) 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/K171571
Methodology: https://510kreport.com/methodology