# K961780: Hemodialysis Introducer Set

- Pathway: 510(k) (Traditional)
- Applicant: Thomas Medical Products, Inc.
- Decided: Dec 24, 1996 after 230 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.
2 later devices descend from it; 1 cites it directly.
1 of 3 devices in its family (counting itself) has 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
- K082063: Prelude Short Sheath Introducer (2008), 1 descendant of its own
- K122190: Prelude 7F Short Sheath Introducer (2012), 0 descendants of its own

Source page: https://510kreport.com/device/K961780
Methodology: https://510kreport.com/methodology