# K252309: PerQseal Introducers

- Pathway: 510(k) (Traditional)
- Applicant: Vivasure Medical Limited
- Decided: Oct 23, 2025 after 91 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171866: Sentrant Introducer Sheath with Hydrophilic Coating, Medtronic Vascular, Inc. (2017) Summary page 5.

## Indications for use
PerQseal Introducer: The PerQseal Introducers are intended to provide access and facilitate the insertion of diagnostic or endovascular devices into femoral vasculature. PerQseal Elite Introducer: The PerQseal Elite Introducers are intended to provide access and facilitate the insertion of diagnostic or endovascular devices into femoral vasculature.

Source page: https://510kreport.com/device/K252309
Methodology: https://510kreport.com/methodology