# K233708: NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)

- Pathway: 510(k) (Traditional)
- Applicant: Synaptic Medical Corporation
- Decided: Feb 16, 2024 after 88 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K964518 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151936: Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle, Synaptic Medical Limited (2015) Summary page 5.

## Indications for use
The NaviGo 12F Steerable Intracardiac Catheter Introducer Kit is intended to introduce various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

Source page: https://510kreport.com/device/K233708
Methodology: https://510kreport.com/methodology