# K945616: Cordis Avanti Catheter Sheath Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corp.
- Decided: Mar 29, 1995 after 134 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.
64 later devices descend from it; 3 cite it directly.
0 of 65 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
- K962746: Cordis Avanti Trans-Radial Catheter Sheath Introducer Kit (1996), 44 descendants of its own
- K082644: Glidesheath (2008), 41 descendants of its own
- 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

## Recalls of this device
- Jan 28, 2010 · Not classified · Z-1421-2010: Sterility compromised: Cordis found a pin hole in one of the packaging tray cavities.On January 28, 2010 Cordis Corporation initiated a recall on their AVANTI + Introducer. During routine inspection, 

Source page: https://510kreport.com/device/K945616
Methodology: https://510kreport.com/methodology