# K190628: FlexSeal Introducer Sheath with Hydrophilic Coating

- Pathway: 510(k) (Traditional)
- Applicant: Freudenberg Medical Mis, Inc.
- Decided: May 30, 2019 after 79 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- 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: 5 generations back to K032073 (2003). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161659: FlexSeal Introducer Sheath with Hydrophilic Coating, Libramedical, Inc. (2016) Summary page 5.

## Recalls of this device
- Feb 21, 2022 · Class II · Z-1016-2022: Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia
- Feb 21, 2022 · Class II · Z-1017-2022: Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia

## 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/K190628
Methodology: https://510kreport.com/methodology