# K160303: Reprocessed Polaris X Steerable Diagnostic EP Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Health, LLC
- Decided: May 10, 2016 after 96 days
- Product code: NLH (Catheter, Recording, Electrode, Reprocessed)
- 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 K924163 (1993). 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)
- K003452: Polaris X Catheters, Model 7000D,7001D,7003D,7004D,7005D,7006D, Ep Technologies, Inc. (2000) Summary page 5.
- K924163: Explorer/360-Polaris-L.E./Jackman Coron Sinus Elec, Boston Scientific Corp (1993) Summary page 5.

## Indications for use
The Reprocessed Polaris X Steerable Diagnostic EP Catheter is intended for temporary use in electrophysiology studies for intracardiac stimulation (pacing) and/or recording of electrical potentials.

Source page: https://510kreport.com/device/K160303
Methodology: https://510kreport.com/methodology