# K954595: Cordis Brite Tip Sheath Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corp.
- Decided: Dec 28, 1995 after 86 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.
28 later devices descend from it; 2 cite it directly.
0 of 29 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
- K970392: Cordis Avanti+Catheter Sheath Introducer System (1997), 25 descendants of its own
- K050962: Merit Prelude Sheath Introducer (2005), 24 descendants of its own
- K070159: Prelude Sheath Introducer (2007), 22 descendants of its own
- K091006: Itg Vascular Access System, Model 300 (2010), 12 descendants of its own
- K100615: Arstasis Access System (2010), 11 descendants of its own

## Recalls of this device
- May 5, 2003 · Not classified · Z-0941-03: Reports of broken or separated tips of the catheter sheath introducers.

Source page: https://510kreport.com/device/K954595
Methodology: https://510kreport.com/methodology