# K220604: EXTesia Introducer Sheath Set

- Pathway: 510(k) (Traditional)
- Applicant: Curatia Medical Co.
- Decided: Apr 27, 2022 after 56 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: 7 generations back to K954234 (1995). 12 ancestors in all.
No later device cites it as a predicate yet.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173831: Glidesheath Slender, Terumo Medical Corporation (2018) Summary page 5.

## Indications for use
The EXTesia Introducer Sheath Set is intended to be inserted percutaneously into a vessel to facilitate placing the interventional or diagnostic devices into a vein or artery.

Source page: https://510kreport.com/device/K220604
Methodology: https://510kreport.com/methodology