# K032569: Short Introducer Sheath

- Pathway: 510(k) (Special)
- Applicant: Rex Medical
- Decided: Sep 16, 2003 after 27 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: 3 generations back to K954234 (1995). 3 ancestors in all.
15 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022170: Inner-Lock Locking Introducer Sheaths, Rex Medical (2003) Summary page 1.

## Most influential descendants
- K033793: Cleaner II Rotational Thrombectomy System (2003), 12 descendants of its own
- K040252: Cleaner Rotational Thrombectomy System Kit (2004), 11 descendants of its own
- K060904: Cleaner Rotational Thrombectomy System (2006), 10 descendants of its own
- K091029: Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM) (2010), 9 descendants of its own
- K120346: Cleaner Rotational Thrombectomy System (2012), 8 descendants of its own

## Indications for use
The Short Introducer Sheaths are used to facilitate placing a catheter through the skin into a graft. The dilator is an accessory device which is used by placing it into the sheaths to create an occlusion and further provide support to the wall of the indwelling system.

Source page: https://510kreport.com/device/K032569
Methodology: https://510kreport.com/methodology