# K090323: Reprocessed Electrophysiology Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Ascent Healthcare Solutions
- Decided: Apr 1, 2009 after 51 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: 4 generations back to K961924 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072012: Reflexion Spiral Variable Radius Catheter, St Jude Medical (2007) Summary page 1.
- K062251: Reflexion Spiral Variable Radius Catheter, Model 402804, St Jude Medical (2006) Summary page 1.

## Indications for use
Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures. In addition, the LASSO® 2515 Variable Circular Mapping Catheter and the Reflexion SpiralTMVariable Radius Catheter are designed for electrophysiological mapping of the atria of the heart.

Source page: https://510kreport.com/device/K090323
Methodology: https://510kreport.com/methodology