# K123990: Sentrant Introducer Sheath with Hydrophilic Coating

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Apr 26, 2013 after 121 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: 3 generations back to K032073 (2003). 5 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902469: Byrd Dilator Sheath Set - Teflon, Medical Engineering and Development Institute (1990) Summary page 1.
- K093791: Gore Dryseal Sheath, W. L. Gore & Associates, Inc. (2010) Summary page 1.

## Most influential descendants
- K140793: Nanostim Introducer Kit (2014), 3 descendants of its own
- K160716: The Nanostim Introducer Kit (2016), 2 descendants of its own
- K171866: Sentrant Introducer Sheath with Hydrophilic Coating (2017), 1 descendant of its own
- K161102: Nanostim Introducer Kit (2016), 1 descendant of its own
- K252309: PerQseal Introducers (2025), 0 descendants of its own

## Indications for use
The Sentrant Introducer Sheath with Hydrophilic Coating is intended to provide a conduit for the insertion of diagnostic or endovascular devices into the vasculature and minimize blood loss associated with such insertions.

Source page: https://510kreport.com/device/K123990
Methodology: https://510kreport.com/methodology