# K101789: Reprocessed Electrophysiology Diagnostic Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Aug 19, 2010 after 52 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: 3 generations back to K961924 (1997). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060757: Inquiry Optima Plus Steerable Electrophysiology Catheter, Irvine Biomedical, Inc. (2006) Summary page 1.
- K053582: Inquiry Afocus II Diagnostic Catheter, Irvine Biomedical, Inc. (2006) Summary page 1.
- 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)
- K946333: Ibi-1000(TM) Electrophysiology Cathter, Irvine Biomedical, Inc. (1995) Summary page 1.

## Indications for use
The reprocessed electrophysiology diagnostic catheters are indicated for temporary use during electrophysiology studies for intracardiac sensing, recording, cardiac stimulation, and for the electrophysiological mapping and evaluation of cardiac structures and arrhythmias.

Source page: https://510kreport.com/device/K101789
Methodology: https://510kreport.com/methodology