# K083121: Neo Mapcath Sensor Stylet

- Pathway: 510(k) (Traditional)
- Applicant: Corpak Medsystems
- Decided: Feb 11, 2009 after 112 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
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
- K093510: Lumenvu Catheter Guidance System (2010), 0 descendants of its own

## Indications for use
The NEO MAPCath sensor stylet, when used in conjunction with the NAVIGATOR locator instrument, is designed to aid in the placement of central venous catheters by providing real-time information as to the position of the catheter inside the body during the catheter insertion procedure.

Source page: https://510kreport.com/device/K083121
Methodology: https://510kreport.com/methodology