# K180785: iSLEEVE Introducer Set

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Jun 22, 2018 after 88 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: 4 generations back to K902469 (1990). 5 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140338: Creganna Tactx Lotus Introducer Set (Small), Creganna Tactx Lotus Introducer Set (Large), Creganna-Tactx Medical (2014) Summary page 4.

## Most influential descendants
- K191871: 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set (2019), 4 descendants of its own
- K230051: 14F iSLEEVE™ Introducer Set (2023), 2 descendants of its own
- K233503: 14F iSLEEVE Introducer Set (2023), 1 descendant of its own
- K250468: iSLEEVE Introducer Set (2025), 0 descendants of its own
- K202330: Impella XR Sheath Set (2020), 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 the ACURATE TF Valve System and ancillary devices. The iSLEEVE Introducer Set is suitable for use in vessels ≥ 5.5 mm. The 15F iSLEEVE Introducer Set is intended to facilitate femoral access to the vascular system for introduction and removal of the LOTUS Edge Valve System and ancillary devices. The iSLEEVE Introducer Set is suitable for use in vessels ≥ 5.9 mm.

Source page: https://510kreport.com/device/K180785
Methodology: https://510kreport.com/methodology