# K171277: Reprocessed Inquiry Steerable Diagnostic EP Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Health, LLC
- Decided: Oct 23, 2017 after 175 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: 1 generation back to K961924 (1997). 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)
- 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.

## Most influential descendants
- K203261: Reprocessed Inquiry Steerable Diagnostic EP Catheter (2021), 0 descendants of its own

## 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/K171277
Methodology: https://510kreport.com/methodology