# K233900: Nordica PV Cryo Mapping Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Synaptic Medical Corporation
- Decided: Sep 6, 2024 after 270 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: 3 generations back to K102588 (2011). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162892: Achieve Advance Mapping Catheter, Medtronic, Inc. (2016) Summary page 5.

## Indications for use
The Nordica PV Cryo Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures (i.e., recording and stimulation only). The Nordica PV Cryo Mapping Catheter is designed to obtain electrograms in the atrial regions of the heart.

Source page: https://510kreport.com/device/K233900
Methodology: https://510kreport.com/methodology