# K140338: Creganna Tactx Lotus Introducer Set (Small), Creganna Tactx Lotus Introducer Set (Large)

- Pathway: 510(k) (Traditional)
- Applicant: Creganna-Tactx Medical
- Decided: Aug 27, 2014 after 198 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 K902469 (1990). 4 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093877: Retroflex 3 Introducer Sheath Set, Models 9120S23 and 9120S26, Edwards Lifesciences, LLC (2010) Summary page 4.

## Most influential descendants
- K180785: iSLEEVE Introducer Set (2018), 7 descendants of its own
- K191871: 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set (2019), 4 descendants of its own
- K230051: 14F iSLEEVE™ Introducer Set (2023), 2 descendants of its own
- K233503: 14F iSLEEVE Introducer Set (2023), 1 descendant of its own
- K250468: iSLEEVE Introducer Set (2025), 0 descendants of its own

## Indications for use
The Lotus Introducer Set is intended to provide femoral access to the vascular system.

Source page: https://510kreport.com/device/K140338
Methodology: https://510kreport.com/methodology