# K211276: Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Health, LLC
- Decided: Sep 15, 2021 after 141 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 K891908 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161464: Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters, Innovative Health, LLC (2016) Summary page 5.
- K891908: Bard (R) Tip Deflecting Electrode Catheter, C.R. Bard, Inc. (1989) Summary page 5.

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

Source page: https://510kreport.com/device/K211276
Methodology: https://510kreport.com/methodology