# K003889: Ancure Sheath Model # 40315, 40320, 40325

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Cardiac and Vascular Surgery
- Decided: Jan 24, 2002 after 402 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
No predicates in its family tree.
18 later devices descend from it; 2 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K031087: Edwards Introducer Sheath (2003), 17 descendants of its own
- K093877: Retroflex 3 Introducer Sheath Set, Models 9120S23 and 9120S26 (2010), 16 descendants of its own
- K140338: Creganna Tactx Lotus Introducer Set (Small), Creganna Tactx Lotus Introducer Set (Large) (2014), 8 descendants of its own
- K180785: iSLEEVE Introducer Set (2018), 7 descendants of its own
- K191871: 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set (2019), 4 descendants of its own

Source page: https://510kreport.com/device/K003889
Methodology: https://510kreport.com/methodology