# K970392: Cordis Avanti+Catheter Sheath Introducer System

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corp.
- Decided: Apr 24, 1997 after 80 days
- Product code: DRE (Dilator, Vessel, For Percutaneous Catheterization)
- Device class: 2
- Regulation: 21 CFR 870.1310
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K945616 (1995). 2 ancestors in all.
25 later devices descend from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954595: Cordis Brite Tip Sheath Introducer, Cordis Corp. (1995) Summary page 1.
- K945616: Cordis Avanti Catheter Sheath Introducer, Cordis Corp. (1995) Summary page 1.

## Most influential descendants
- 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
- K102728: Arstasis Access System (2010), 10 descendants of its own

## Recalls of this device
- Jun 9, 2021 · Class II · Z-2079-2021: The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.
- Dec 31, 2015 · Class II · Z-1174-2016: Incorrect cannula of the sheath introducer (smaller than intended).

## Indications for use
The Avanti + Catheter Sheath Introducer is indicated for use in arterial and venous procedures requiring percutaneous introduction of catheters and other intravascular devices.

Source page: https://510kreport.com/device/K970392
Methodology: https://510kreport.com/methodology