# K142357: DuraSheath Introducer Sheath System

- Pathway: 510(k) (Traditional)
- Applicant: Contract Medical International, GmbH
- Decided: Jun 25, 2015 after 304 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: 6 generations back to K924607 (1993). 7 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091329: Pinnacle Destination Peripheral Guiding Sheath, Terumo Medical Corp. (2009) Summary page 4.
- K100799: Fortress Introducer Sheath System Model 358813, 358814, 358815, Contract Medical Intl. GmbH (2011) Summary page 4.

## Most influential descendants
- K181463: DuraSheath Introducer Sheath System (2018), 5 descendants of its own
- K221914: Catapult Guide Sheath (2022), 2 descendants of its own
- K240957: Catapult Guide Sheath (2024), 1 descendant of its own
- K211405: Prelude Guide Sheath (2021), 1 descendant of its own
- 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 (2025), 0 descendants of its own

## Indications for use
The DuraSheath Introducer Sheath System is indicated to be used for introduction of interventional and diagnostic devices into the human vasculature, including but not limited to femoral access via a contralateral approach to access the popliteal and infrapopliteal arteries.

Source page: https://510kreport.com/device/K142357
Methodology: https://510kreport.com/methodology