# K161659: FlexSeal Introducer Sheath with Hydrophilic Coating

- Pathway: 510(k) (Traditional)
- Applicant: Libramedical, Inc.
- Decided: Jul 15, 2016 after 29 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). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121234: Gore (R) Dryseal Sheath with Hydrophilic Coating, W. L. Gore & Associates, Inc. (2012) Summary page 4.

## Most influential descendants
- K190628: FlexSeal Introducer Sheath with Hydrophilic Coating (2019), 0 descendants of its own

## Indications for use
The FlexSeal™ Introducer Sheath with Hydrophilic Coating is intended to be placed in the peripheral vasculature to provide a conduit for the introduction of diagnostic or interventional devices and to minimize blood loss associated with such insertions

Source page: https://510kreport.com/device/K161659
Methodology: https://510kreport.com/methodology