# K171866: Sentrant Introducer Sheath with Hydrophilic Coating

- Pathway: 510(k) (Special)
- Applicant: Medtronic Vascular, Inc.
- Decided: Dec 20, 2017 after 181 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: 4 generations back to K032073 (2003). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123990: Sentrant Introducer Sheath with Hydrophilic Coating, Medtronic Vascular (2013) Summary page 4.

## Most influential descendants
- 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/K171866
Methodology: https://510kreport.com/methodology