# K254248: Introducer Sheath Set

- Pathway: 510(k) (Traditional)
- Applicant: Cardiocycle Medical (Suzhou) Co., Ltd.
- Decided: Apr 23, 2026 after 115 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: 1 generation back to K251838 (2025). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251838: Introducer Sheath Set, Cardiocycle Medical (Suzhou) Co., Ltd. (2025) Summary page 5.

## Indications for use
The Introducer Sheath set is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions.

Source page: https://510kreport.com/device/K254248
Methodology: https://510kreport.com/methodology