# K233503: 14F iSLEEVE Introducer Set

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Nov 30, 2023 after 30 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: 7 generations back to K902469 (1990). 8 ancestors in all.
1 later device descends 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)
- K230051: 14F iSLEEVE™ Introducer Set, Boston Scientific Corporation (2023) Summary page 5.

## Most influential descendants
- 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/K233503
Methodology: https://510kreport.com/methodology