# K181463: DuraSheath Introducer Sheath System

- Pathway: 510(k) (Traditional)
- Applicant: Contract Medical International, GmbH
- Decided: Dec 13, 2018 after 192 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.
5 later devices descend from it; 2 cite 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)
- K142357: DuraSheath Introducer Sheath System, Contract Medical International, GmbH (2015) Summary page 4.
- K091329: Pinnacle Destination Peripheral Guiding Sheath, Terumo Medical Corp. (2009) Summary page 4.

## Most influential descendants
- 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
- K223872: Low Profile Companion Sheath (2023), 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 peripheral (and coronary) vasculature. The device is also intended to be used within a pediatric population.

Source page: https://510kreport.com/device/K181463
Methodology: https://510kreport.com/methodology