# K081329: Reprocessed Electrophysiology Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Ascent Healthcare Solutions
- Decided: Jul 9, 2008 after 58 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 K961924 (1997). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042775: Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable Electrophysiology Catheter, Irvine Biomedical, Inc. (2004) Summary page 1.
- K010471: Afocus Electropysiology Catheter System, Models 81550, 81567, 81568, 81569, Irvine Biomedical, Inc. (2001) Summary page 1.
- K990958: Orthogonal EP Catheters, Irvine Biomedical, Inc. (1999) Summary page 1.
- K982232: Modification of the Ibi-1100 Steerable Electrophysiology Catheter System, Irvine Biomedical, Inc. (1998) Summary page 1.
- K961924: Ibi-1100 Steerable Electrophysiology Catheter System, Irvine Biomedical, Inc. (1997) Summary page 1.
- K946333: Ibi-1000(TM) Electrophysiology Cathter, Irvine Biomedical, Inc. (1995) Summary page 1.

## Most influential descendants
- K112232: Reprocessed Electrophysiology Catheters (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.

Source page: https://510kreport.com/device/K081329
Methodology: https://510kreport.com/methodology