# K233207: Polaris X™ Unidirectional Steerable Diagnostic Catheter

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Oct 27, 2023 after 29 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 K003452 (2000). 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)
- K211494: Polaris X Unidirectional Steerable Diagnostic Catheter, Boston Scientific Corporation (2021) Summary page 5.

## Indications for use
The Polaris X catheter is indicated for use to diagnose cardiac arrhythmia.

Source page: https://510kreport.com/device/K233207
Methodology: https://510kreport.com/methodology