# K972803: Tracer O-T-W Mapping Device

- Pathway: 510(k) (Traditional)
- Applicant: Cardima, Inc.
- Decided: May 11, 1999 after 652 days
- Product code: DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording)
- Device class: 2
- Regulation: 21 CFR 870.1220
- 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 K955802 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955802: Pathfinder, Cardima, Inc. (1997) Summary page 1.

## Indications for use
The Tracer diagnostic mapping device is intended for use in cardiac electrophysiology studies. This catheter can be used to temporarily record epicardial electrical signals from the coronary sinus. The Tracer catheter can be used to temporarily pace during the mapping procedure.

Source page: https://510kreport.com/device/K972803
Methodology: https://510kreport.com/methodology