# K250439: Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm (US-34045-F-ST-H); Catapult Guide Sheath; 4F; 60cm (US-34060-F-ST-H); Catapult Guide Sheath; 4F; 90cm (US-34090-F-ST-H); Catapult Guide Sheath; 4F; 130cm (US-34130-F-ST-H); Catapult Guide Sheath; 5F; 15cm (US-35015-F-ST-H); Catapult Guide Sheath; 5F; 45cm (US-35045-F-ST-H); Catapult Guide Sheath; 5F; 45cm; Hockey Stick (US-35045-F-HS-H); Catapult Guide Sheath; 5F; 45cm; Multipurpose (US-35045-F-MP-H); Ca

- Pathway: 510(k) (Special)
- Applicant: Contract Medical International, GmbH
- Decided: Mar 16, 2025 after 30 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: 10 generations back to K924607 (1993). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240957: Catapult Guide Sheath, Contract Medical International, GmbH (2024) Summary page 5.

## Indications for use
The Catapult Guide Sheath is indicated to be used for introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature. The COMPASS Guiding Introducer Sheath is indicated to be used for introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature. The device is also intended to be used within a pediatric population. 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 haemostasis during diagnostic and interventional procedures.

Source page: https://510kreport.com/device/K250439
Methodology: https://510kreport.com/methodology