# K003452: Polaris X Catheters, Model 7000D,7001D,7003D,7004D,7005D,7006D

- Pathway: 510(k) (Special)
- Applicant: Ep Technologies, Inc.
- Decided: Dec 7, 2000 after 30 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
No predicates in its family tree.
9 later devices descend from it; 5 cite it directly.
0 of 10 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
- K211494: Polaris X Unidirectional Steerable Diagnostic Catheter (2021), 1 descendant of its own
- K043393: Reprocessed EP Technologies Electrophysiology Catheters (2005), 1 descendant of its own
- K233207: Polaris X™ Unidirectional Steerable Diagnostic Catheter (2023), 0 descendants of its own
- K160303: Reprocessed Polaris X Steerable Diagnostic EP Catheter (2016), 0 descendants of its own

Source page: https://510kreport.com/device/K003452
Methodology: https://510kreport.com/methodology