# K924163: Explorer/360-Polaris-L.E./Jackman Coron Sinus Elec

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Sep 3, 1993 after 380 days
- Product code: DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 6 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012708: Electrophysiology Catheter (2002), 5 descendants of its own
- K043393: Reprocessed EP Technologies Electrophysiology Catheters (2005), 1 descendant of its own
- K023180: Vanguard Reprocessed Diagnostic Electrophysiology Catheters (2002), 1 descendant of its own
- K230503: Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable (2023), 0 descendants of its own
- K160303: Reprocessed Polaris X Steerable Diagnostic EP Catheter (2016), 0 descendants of its own

## Recalls of this device
- Jun 26, 2007 · Not classified · Z-1191-2007: Product is mislabeled as hexapolar (6 electrodes), but is actually quadripolar (4 electrodes).

Source page: https://510kreport.com/device/K924163
Methodology: https://510kreport.com/methodology