# K203261: Reprocessed Inquiry Steerable Diagnostic EP Catheter

- Pathway: 510(k) (Special)
- Applicant: Innovative Health, LLC
- Decided: Mar 5, 2021 after 120 days
- Product code: DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording)
- 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171277: Reprocessed Inquiry Steerable Diagnostic EP Catheter, Innovative Health, LLC (2017) Summary page 5.
- K982232: Modification of the Ibi-1100 Steerable Electrophysiology Catheter System, Irvine Biomedical, Inc. (1998) Summary page 5.
- K961924: Ibi-1100 Steerable Electrophysiology Catheter System, Irvine Biomedical, Inc. (1997) Summary page 5.

## Indications for use
The Reprocessed Inquiry Steerable Diagnostic Electrophysiology Catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle.

Source page: https://510kreport.com/device/K203261
Methodology: https://510kreport.com/methodology