# K160716: The Nanostim Introducer Kit

- Pathway: 510(k) (Special)
- Applicant: St. Jude Medical, Inc.
- Decided: Apr 14, 2016 after 30 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
Longest line of descent: 5 generations back to K032073 (2003). 8 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140793: Nanostim Introducer Kit, St. Jude Medical, Inc. (2014) Summary page 4.

## Most influential descendants
- K161102: Nanostim Introducer Kit (2016), 1 descendant of its own
- K211989: Aveir Introducer (2021), 0 descendants of its own

## Indications for use
The Nanostim™ Introducer Kit is intended to provide a conduit into the venous system for insertion of diagnostic and other interventional devices.

Source page: https://510kreport.com/device/K160716
Methodology: https://510kreport.com/methodology