# K203179: Fortress Introducer Sheath System

- Pathway: 510(k) (Special)
- Applicant: Contract Medical International, GmbH
- Decided: Nov 20, 2020 after 25 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 K924607 (1993). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153197: Fortress Introducer Sheath SYstem, Contract Medical International, GmbH (2016) Summary page 4.

## Indications for use
The Fortress Introducer Sheath System is intended to provide access and to facilitate percutaneous introduction of guide wires, catheters and other devices into the femoral, popliteal and infrapopliteal arteries while maintaining hemostasis during diagnostic and interventional procedures.

Source page: https://510kreport.com/device/K203179
Methodology: https://510kreport.com/methodology