# K153197: Fortress Introducer Sheath SYstem

- Pathway: 510(k) (Special)
- Applicant: Contract Medical International, GmbH
- Decided: Jan 11, 2016 after 68 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K924607 (1993). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100799: Fortress Introducer Sheath System Model 358813, 358814, 358815, Contract Medical Intl. GmbH (2011) Summary page 4.

## Most influential descendants
- K203179: Fortress Introducer Sheath System (2020), 0 descendants of its own
- K170616: van Andel Dilatation Catheter (2017), 0 descendants of its own

## Recalls of this device
- Jul 30, 2025 · Class II · Z-2532-2025: Units may have been packaged with an incorrect pouch label, which lists the reference number and unique device identifier of the 4F version of the device, rather than the packaged 6F version.

## 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/K153197
Methodology: https://510kreport.com/methodology