# K250305: Reprocessed Agilis NxT Steerable Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Health
- Decided: Jan 7, 2026 after 338 days
- Product code: PNE (Reprocessed Catheter Introducer)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K000248 (2000). 71 ancestors in all.
No later device cites it as a predicate yet.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251211: ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™, Abbott Medical (2025). Cleared while this submission was under review Summary page 6.

## Indications for use
The Reprocessed Agilis NxT Steerable Introducer is indicated for the introduction of various cardiovascular catheters into the heart, including the left side of the heart, during the treatment of cardiac arrhythmias.

Source page: https://510kreport.com/device/K250305
Methodology: https://510kreport.com/methodology