# K211494: Polaris X Unidirectional Steerable Diagnostic Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Sep 14, 2021 after 124 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 K003452 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003452: Polaris X Catheters, Model 7000D,7001D,7003D,7004D,7005D,7006D, Ep Technologies, Inc. (2000) Summary page 4.

## Most influential descendants
- K233207: Polaris X™ Unidirectional Steerable Diagnostic Catheter (2023), 0 descendants of its own

## Indications for use
The catheter is intended for temporary use in electrophysiological studies for intracardiac stimulation (pacing) and/or recording of electrical potentials.

Source page: https://510kreport.com/device/K211494
Methodology: https://510kreport.com/methodology