# K183649: Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable

- Pathway: 510(k) (Traditional)
- Applicant: Baylis Medical Company, Inc.
- Decided: Jun 7, 2019 after 163 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 K970853 (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)
- K970853: Pathfinder 3MM Mapping Microcatheter (01-082001), Cardima, Inc. (1997) Summary page 4.

## Indications for use
The Diagnostic Fixed Electrophysiology Catheter and Diagnostic Electrophysiology Cable are intended for electrogram recording and pacing during diagnostic electrophysiology studies.

Source page: https://510kreport.com/device/K183649
Methodology: https://510kreport.com/methodology