# K914090: Daig Fast Cath (TM) Introducer, Modification

- Pathway: 510(k) (Traditional)
- Applicant: Daig Corp.
- Decided: Oct 28, 1991 after 47 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K093130: Engage TR Introducer (2009), 0 descendants of its own
- K092575: Engage/Engage TR (2009), 0 descendants of its own

## Recalls of this device
- Dec 9, 2019 · Class II · Z-0789-2020: Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F devices.

Source page: https://510kreport.com/device/K914090
Methodology: https://510kreport.com/methodology