# Mc3 Incorporated

- Location (FDA's records): Dexter, MI
- FDA decisions: 6 (2017–2023): 6 510(k) clearances
- Names in FDA's records: Mc3 Incorporated (4); Mc3, Inc. (2)
- Product codes: PZS (3), BYS (2), DRE (1)
- Predicates its devices cite: 5 (3 its own); citations of its devices by later devices: 4 (3 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Avalon Laboratories, LLC: 2 (https://510kreport.com/company/avalon-laboratories)

## Firms that cite its devices most
- Cardiacassist, Inc.: 1 (https://510kreport.com/company/cardiacassist)

## Its most-cited devices
- K180151: MC3 Jugular Dual Lumen Catheter (2018), cited by 2
- K191935: Nautilus Smart ECMO Module (2020), cited by 1
- K171610: MC3 QuickFlow Dual Lumen Catheter (2017), cited by 1

## Recent decisions
- K232767: Nautilus VF ECMO Oxygenator (Oct 4, 2023)
- K203409: MC3 Crescent Jugular Dual Lumen Catheter (May 3, 2021)
- K191935: Nautilus Smart ECMO Module (Apr 9, 2020)
- K182914: MC3 Vascular Access Kit 21030 (Oct 29, 2018)
- K180151: MC3 Jugular Dual Lumen Catheter (Jul 16, 2018)
- K171610: MC3 QuickFlow Dual Lumen Catheter (Nov 16, 2017)

Source page: https://510kreport.com/company/mc3