# K230051: 14F iSLEEVE™ Introducer Set

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Feb 3, 2023 after 28 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K902469 (1990). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191871: 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set, Boston Scientific Corporation (2019) Summary page 4.

## Most influential descendants
- K233503: 14F iSLEEVE Introducer Set (2023), 1 descendant of its own
- K250468: iSLEEVE Introducer Set (2025), 0 descendants of its own

## Recalls of this device
- Feb 20, 2024 · Class II · Z-1390-2024: Boston Scientific is conducting a removal of specific batches of the iSLEEVETM 14F Expandable Introducer Set due to complaints associated with a hemostatic valve leak.

## Indications for use
The 14F 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/K230051
Methodology: https://510kreport.com/methodology