# K203793: RithmID-SD Steerable Diagnostic Electrophysiology Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Synaptic Medical Corporation
- Decided: Feb 14, 2022 after 413 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: 2 generations back to K022380 (2002). 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)
- K160390: Map-it Diagnostic Mapping Catheters, Access Point Technologies Ep, Inc. (2016) Summary page 4.

## Indications for use
The RithmID-SD Steerable Diagnostic Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

Source page: https://510kreport.com/device/K203793
Methodology: https://510kreport.com/methodology