# K082023: Reprocessed Electrophysiology Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Ascent Healthcare Solutions
- Decided: Sep 16, 2008 after 62 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: 2 generations back to K002333 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031161: Variable Lasso 2515 Circular Mapping Catheter, Biosense Webster, Inc. (2003) Summary page 1.
- K002333: Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model D-1220, Biosense Webster, Inc. (2000) Summary page 1.

## Most influential descendants
- K112292: Reprocessed 2515 Nav Variable Electrophysiology Catheter (2011), 0 descendants of its own

## Indications for use
Reprocessed Electrophysiology (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 is designed for electrophysiological mapping of the atria of the heart.

Source page: https://510kreport.com/device/K082023
Methodology: https://510kreport.com/methodology