# K250468: iSLEEVE Introducer Set

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific
- Decided: Mar 20, 2025 after 30 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: 8 generations back to K902469 (1990). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233503: 14F iSLEEVE Introducer Set, Boston Scientific Corporation (2023) Summary page 5.

## Indications for use
The iSLEEVE™ Introducer Set is intended to facilitate femoral access to the vascular system for introduction and removal of cardiovascular devices. The iSLEEVE™ Introducer Set is suitable for use in vessels ≥ 5.5 mm diameter.

Source page: https://510kreport.com/device/K250468
Methodology: https://510kreport.com/methodology