# K954317: Diag Fast-Cath Duo & Trio Removable Hemostasis Adapters W/Sideports & 3-Way Stopcocks

- Pathway: 510(k) (Traditional)
- Applicant: Daig Corp.
- Decided: Nov 28, 1995 after 74 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Dec 9, 2019 · Class II · Z-0783-2020: Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices.
- Oct 14, 2014 · Class II · Z-0108-2015: St. Jude Medical is conducting a voluntary recall of SMJ Batch # 4641580 of the Fast-Cath Trio" Hemostasis Introducer, Catalog number 406308. The inner diameter of the 10F dilator is too small, such t

Source page: https://510kreport.com/device/K954317
Methodology: https://510kreport.com/methodology