# K170373: Flextra Steerable Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Rhythm Xience, Inc. (Rxi)
- Decided: Feb 27, 2017 after 20 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 4 (0 Class I)
- 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 4.

## Most influential descendants
- K193509: AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX (2020), 3 descendants of its own
- K210685: AcQCross Qx Integrated Transseptal Dilator/Needle (2021), 2 descendants of its own
- K233691: FlexCath Cross Transseptal Solution (2023), 0 descendants of its own
- K220047: AcQCross Qx Integrated Transseptal Dilator/Needle (2022), 0 descendants of its own

## Recalls of this device
- Feb 25, 2020 · Class II · Z-1769-2020: It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary emboli
- Feb 25, 2020 · Class II · Z-1768-2020: It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary emboli
- Feb 25, 2020 · Class II · Z-1771-2020: It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary emboli
- Feb 25, 2020 · Class II · Z-1770-2020: It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary emboli

## Indications for use
The Flextra™ Steerable Introducer 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/K170373
Methodology: https://510kreport.com/methodology