# K161464: Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Health, LLC
- Decided: Sep 30, 2016 after 127 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: 1 generation back to K891908 (1989). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891908: Bard (R) Tip Deflecting Electrode Catheter, C.R. Bard, Inc. (1989) Summary page 5.

## Most influential descendants
- K211276: Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters (2021), 0 descendants of its own

## Indications for use
The Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.

Source page: https://510kreport.com/device/K161464
Methodology: https://510kreport.com/methodology