# K973057: 1.4 FR Mapcath Sensor Stylet

- Pathway: 510(k) (Traditional)
- Applicant: Navion Biomedical Corp.
- Decided: Nov 12, 1997 after 89 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: 1 generation back to K901263 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935380: Vascular Access Catheter Accessories, Bard Access Systems, Inc. (1995) Summary page 1.
- K901263: Navion Smart-Wire (TM) Catheter Location System, Navion Biomedical Corp. (1990) Summary page 1.

## Indications for use
The 1.4 Fr MAPCath Sensor Stylet is designed to be used with the NAVIGATOR catheter locator instrument to aid in the placement of central venous catheters (CVCs) by indicating the position and direction of the CVC tip inside the body during the catheter insertion procedure.

Source page: https://510kreport.com/device/K973057
Methodology: https://510kreport.com/methodology