# K202584: iSleeve Introducer Set

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Oct 6, 2020 after 28 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: 6 generations back to K902469 (1990). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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.

## Indications for use
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/K202584
Methodology: https://510kreport.com/methodology