# K230503: Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific
- Decided: Apr 25, 2023 after 60 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 K913375 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081576: Blazer DX-20 Diagnostic Catheter, Boston Scientific Corp (2009) Summary page 4.
- K924163: Explorer/360-Polaris-L.E./Jackman Coron Sinus Elec, Boston Scientific Corp (1993) Summary page 4.

## Indications for use
Blazer Dx-20 Catheter Cable: The BSC Cables are intended to be used with the BSC Cardiac Diagnostic Catheters during an electrophysiology procedure for intracardiac stimulation (pacing) and/or recording of electrical potentials. Polaris X Catheter Cable: The BSC Cables are intended to be used with the BSC Cardiac Diagnostic Catheters during an electrophysiology procedure for intracardiac stimulation (pacing) and/or recording of electrical potentials.

Source page: https://510kreport.com/device/K230503
Methodology: https://510kreport.com/methodology