# K110627: Nexsite 9FR Dual Lumen Critical Care Central Venous Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Marvao Medical Devices, Ltd.
- Decided: Aug 12, 2011 after 161 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K001901 (2000). 21 ancestors in all.
5 later devices descend from it; 1 cites it directly.
2 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061179: Powerhickman Long-Term Intravascular Catheter, C.R. Bard, Inc. (2006) Summary page 1.
- K053345: Pro-Line CT Power Injectable CVC, Models CTLINES5S, CTLINE6D, Medcomp (2006) Summary page 1.

## Most influential descendants
- K121933: Nexsite HD Hemodialysis Catheter for Long Term Use (28CM) Nexsite HD Hemodialysis Catheter for Long Term Use (24CM) (2013), 4 descendants of its own
- 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 9Fr Dual Lumen Critical Care Central Venous Catheter is indicated for long-term access to the Central Venous System. It is designed for administering IV fluids, blood products, drugs, and parenteral nutrition as well as blood withdrawal and power injection of contrast media. The maximum pressure of power injectors used with the NexSite device may not exceed 300 psi.

Source page: https://510kreport.com/device/K110627
Methodology: https://510kreport.com/methodology