# K890766: Catheter Introducer Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Applied Vascular Devices, Inc.
- Decided: Sep 18, 1989 after 215 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.
5 later devices descend from it; 3 cite it directly.
0 of 6 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
- K963886: EVS (1997), 2 descendants of its own
- K070865: Expanding Vascular Sheath (2007), 1 descendant of its own
- K041506: Intravascular Access Introducer Sheath (2004), 1 descendant of its own
- K102925: Nexgen Expandable Catheter (2011), 0 descendants of its own
- K063658: Intravascular Introducer System (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K890766
Methodology: https://510kreport.com/methodology