# K253652: Genie MAX Large Bore Introducer Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Cultiv8 1, LLC
- Decided: Jan 22, 2026 after 63 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: 5 generations back to K032073 (2003). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160254: GORE DrySeal Flex Introducer Sheath, W. L. Gore & Associates, Inc. (2016) Summary page 5.

## Indications for use
The Cultiv8 Genie MAX is intended to be inserted into the vasculature to provide a conduit for introducing intravascular devices while providing a hemostatic seal to minimize blood loss.

Source page: https://510kreport.com/device/K253652
Methodology: https://510kreport.com/methodology