# K251838: Introducer Sheath Set

- Pathway: 510(k) (Traditional)
- Applicant: Cardiocycle Medical (Suzhou) Co., Ltd.
- Decided: Oct 21, 2025 after 127 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) GORE® DrySeal Flex Introducer Sheath Set: named in the summary without a submission number

## Most influential descendants
- K254248: Introducer Sheath Set (2026), 0 descendants of its own

## 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/K251838
Methodology: https://510kreport.com/methodology