# K181817: transGlideXT Expandable Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Transaortic Medical, Inc.
- Decided: Mar 26, 2019 after 260 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K092014 (2009). 3 ancestors in all.
No later device cites it as a predicate yet.
2 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152194: transGlide Expandable Introducer, Transaortic Medical, Inc. (2016) Summary page 5.

## Recalls of this device
- May 12, 2020 · Class I · Z-2039-2020: Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)

## Indications for use
The transGlideXT Expandable Introducer is intended to be inserted into the femoral artery, over a guidewire, and once expanded, to provide a guide for catheters and/or devices introduced into the femoral iliac arteries.

Source page: https://510kreport.com/device/K181817
Methodology: https://510kreport.com/methodology