# K100799: Fortress Introducer Sheath System Model 358813, 358814, 358815

- Pathway: 510(k) (Traditional)
- Applicant: Contract Medical Intl. GmbH
- Decided: Feb 25, 2011 after 340 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 K924607 (1993). 6 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073035: Prelude and Prelude Pro Sheath Introducers, Merit Medical Systems, Inc. (2007) Summary page 1.
- K091329: Pinnacle Destination Peripheral Guiding Sheath, Terumo Medical Corp. (2009) Summary page 1.

## Most influential descendants
- K142357: DuraSheath Introducer Sheath System (2015), 6 descendants of its own
- K181463: DuraSheath Introducer Sheath System (2018), 5 descendants of its own
- K221914: Catapult Guide Sheath (2022), 2 descendants of its own
- K153197: Fortress Introducer Sheath SYstem (2016), 2 descendants of its own
- K240957: Catapult Guide Sheath (2024), 1 descendant of its own

## 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 while maintaining hemostasis during diagnostic and interventional procedures.

Source page: https://510kreport.com/device/K100799
Methodology: https://510kreport.com/methodology