# Contract Medical International, GmbH

- Location (FDA's records): Dresden, DE
- FDA decisions: 7 (2015–2025): 7 510(k) clearances
- Product codes: DYB (7)
- 510(k) review time since 2016: median 49 days, against 79 for FDA's reviews in the same codes and years (4 of 6 faster)
- Predicates its devices cite: 9 (5 its own); citations of its devices by later devices: 7 (5 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Terumo Medical Corp.: 2 (https://510kreport.com/company/terumo-medical)
- Contract Medical Intl. GmbH: 2 (https://510kreport.com/company/contract-medical-intl)

## Firms that cite its devices most
- Merit Medical Systems, Inc.: 1 (https://510kreport.com/company/merit-medical-systems)
- Cook, Inc.: 1 (https://510kreport.com/company/cook)

## Its most-cited devices
- K181463: DuraSheath Introducer Sheath System (2018), cited by 2
- K153197: Fortress Introducer Sheath SYstem (2016), cited by 2
- K142357: DuraSheath Introducer Sheath System (2015), cited by 1
- K240957: Catapult Guide Sheath (2024), cited by 1
- K221914: Catapult Guide Sheath (2022), cited by 1

## Recent decisions
- 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 (Mar 16, 2025)
- K240957: Catapult Guide Sheath (Aug 14, 2024)
- K221914: Catapult Guide Sheath (Jul 29, 2022)
- K203179: Fortress Introducer Sheath System (Nov 20, 2020)
- K181463: DuraSheath Introducer Sheath System (Dec 13, 2018)
- K153197: Fortress Introducer Sheath SYstem (Jan 11, 2016)
- K142357: DuraSheath Introducer Sheath System (Jun 25, 2015)

Source page: https://510kreport.com/company/contract-medical-international