# K241370: Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED)

- Pathway: 510(k) (Special)
- Applicant: Abbott Medical
- Decided: Jun 13, 2024 after 30 days
- Product code: DYB (Introducer, Catheter)
- 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: 3 generations back to K964518 (1997). 5 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061363: Agilis NXT Steerable Introducer, St Jude Medical (2006) Summary page 5.

## Most influential descendants
- K243493: Agilis NxT Steerable Introducer Dual-Reach (2024), 3 descendants of its own
- 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™ (2025), 2 descendants of its own
- K250305: Reprocessed Agilis NxT Steerable Introducer (2026), 0 descendants of its own
- K250314: Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer (2025), 0 descendants of its own

## Indications for use
The Agilis NxT Steerable Introducer Dual-Reach™ is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

Source page: https://510kreport.com/device/K241370
Methodology: https://510kreport.com/methodology