# K093510: Lumenvu Catheter Guidance System

- Pathway: 510(k) (Traditional)
- Applicant: Sonosite,Inc.
- Decided: Aug 23, 2010 after 284 days
- Product code: OMF (Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position)
- 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: 7 generations back to K001901 (2000). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083121: Neo Mapcath Sensor Stylet, Corpak Medsystems (2009) Summary page 1.
- K081625: Flowpicc Stylet, Vasonova, Inc. (2008) Summary page 1.
- K052908: Intraredx Nir Imaging System, Model MC-5, Infraredx, Inc. (2006) Summary page 1.

## Indications for use
The LumenVUTM Catheter Guidance System is intended to aid in the placement of peripherally inserted central catheters (P1CC) by providing real-time visual navigation of the catheter tip. The system may be used by trained caregivers in hospitals or other healthcare facilities.

Source page: https://510kreport.com/device/K093510
Methodology: https://510kreport.com/methodology